DiamondTemp™ Ablation System for the Treatment of Paroxys... | NCT03334630

Label	Type	Description	Intervention Names
DiamondTemp Ablation Catheter	Experimental	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter	Device: DiamondTemp Ablation catheter
TactiCath Quartz Ablation Catheter	Active Comparator	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter	Device: TactiCath Quartz Ablation catheter

Name	Type	Description	Arm Group Labels	Other Names
DiamondTemp Ablation catheter	Device	a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	DiamondTemp Ablation Catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)	The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: Atrioesophageal fistula Bleeding complication Cardiac tamponade / perforation Death Extended hospitalization Myocardial infarction Pericarditis Phrenic nerve paralysis Pulmonary edema Pulmonary vein stenosis Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications	Within 30-days or 6-months after index ablation procedure
Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).	The primary effectiveness failure is defined by any of the following events: Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period DC cardioversion for AF, AFL or AT during the effectiveness evaluation period A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period More than one (1) repeat ablation procedure during the blanking period	3-12M (3-12 months) after index ablation procedure

Secondary Outcomes

Measure	Description	Time Frame
Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)	Mean duration of individual RF ablations (seconds) during the index ablation procedure	Index ablation procedure
Mean Cumulative RF Time Per Procedure (Minutes)

Eligibility Module

Eligibility Criteria

STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:

Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.
At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
Refractory to at least one Class I-IV AAD for treatment of PAF.
Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
Subject is willing and able to provide written consent.

STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:

At time of enrollment and/or prior to procedure:

AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
LA diameter > 5.5 cm.
LVEF < 35%.
Currently NYHA Class III or IV or exhibits uncontrolled heart failure.
BMI > 40 kg/m2.
LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.
Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
Coagulopathy, bleeding diathesis or suspected procoagulant state
Sepsis, active systemic infection or fever (>100.5°F / 38°C) within a week prior to the ablation procedure.
Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
Life expectancy < 12 months based on medical history or the medical judgement of the investigator.

Within 1 month of enrollment or just prior to procedure:
Documented LA thrombus upon imaging.
Creatinine >2.5mg/dl or creatinine clearance <30mL/min.

Within 2 months of enrollment:
Regularly (uninterrupted) prescribed amiodarone.

Within 3 months of enrollment:
Significant GI bleed.
MI, unstable angina, cardiac surgery or coronary intervention.

Within 6 months of enrollment:
CABG procedure.
ICD, CRT leads or pacemaker implant procedure.
Documented stroke, CVA, TIA or suspected neurological event.

Within 12 months of enrollment:
An episode of AF lasting >7 days in duration.

Name	Affiliation	Role
Josef Kautzner, MD, PhD	Institut klinické a experimentální medicíny (IKEM)	Principal Investigator
William Maddox, MD	University of Alabama at Birmingham	Principal Investigator
Tom McElderry, MD	University of Alabama at Birmingham	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Grandview Medical Center		Birmingham	Alabama	35242	United States
University Of Alabama

PubMed Identifier	Type	Citation	Retractions
28750697	Background	Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.
33516712	Derived

ID	Title	Description
FG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using the DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
FG001	TactiCath Quartz Ablation Catheter

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Revision I	Apr 1, 2020	Oct 21, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)

The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device.

The primary safety device- or procedure-related SAE composite will be the combined rate of the following events:

Atrioesophageal fistula
Bleeding complication
Cardiac tamponade / perforation
Death
Extended hospitalization
Myocardial infarction
Pericarditis
Phrenic nerve paralysis
Pulmonary edema
Pulmonary vein stenosis
Stroke post-ablation
Thromboembolism
Transient ischemic attack (TIA) post-ablation
Vagal nerve injury
Vascular access complications

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

Within 30-days or 6-months after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants	OG000239 OG001243

Title

Denominators

Categories

Title	Measurements
Free from primary safety event	OG000231 OG001227
Not free from primary safety event	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.	Farrington-Manning non-inferiority test		<0.0001	The a priori threshold for statistical significance is 0.025.	Risk Difference (RD)	0.0324			2-Sided	95	-0.0132	0.0779			Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324		Non-Inferiority

Primary

Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).

The primary effectiveness failure is defined by any of the following events:

Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure
Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period
DC cardioversion for AF, AFL or AT during the effectiveness evaluation period
A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period
Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period
Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period
More than one (1) repeat ablation procedure during the blanking period

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

3-12M (3-12 months) after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Secondary

Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)

Mean duration of individual RF ablations (seconds) during the index ablation procedure

Subjects with measure available.

Posted

Mean

Standard Deviation

seconds

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants	OG000

Secondary

Mean Cumulative RF Time Per Procedure (Minutes)

Mean cumulative RF time per procedure (minutes) during the index ablation procedure

Subjects with measure available.

Posted

Mean

Standard Deviation

minutes

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants	OG000

Secondary

Freedom From a Composite of SAE Occurring Within 7-days

Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.

The device- or procedure-related SAE composite will be the combined rate of the following events:

Atrioesophageal fistula
Bleeding complication
Cardiac tamponade / perforation
Death
Extended hospitalization
Myocardial infarction
Pericarditis
Phrenic nerve paralysis
Pulmonary edema
Pulmonary vein stenosis
Stroke post-ablation
Thromboembolism
Transient ischemic attack (TIA) post-ablation
Vagal nerve injury
Vascular access complications

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

Within 7-days after the index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Secondary

Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).

Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

3-12 months after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Rate of Acute Procedural Success

Rate of acute procedural success is defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV.

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.

Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from documented AF, AT and AFL at 12 months.

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

Index ablation procedure through 12-months after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.

Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from ALL primary effectiveness endpoint failure criteria.

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

Index ablation procedure through 12-months after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts

Secondary

Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)

Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire

Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure.

The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome.

Subjects with measure available.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 6-months after index ablation and 12-months after index ablation

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Secondary

Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)

Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure.

The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome.

Subjects with measure available.

Posted

Mean

Standard Deviation

score on a scale

Baseline, pre-discharge after index ablation and 12-months after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Secondary

Total Procedure Time (Minutes)

Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed.

Subjects with measure available.

Posted

Mean

Standard Deviation

minutes

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)

Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI.

Subjects with measure available.

Posted

Mean

Standard Deviation

minutes

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Total Treatment Device Time (Minutes)

Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter.

Subjects with measure available.

Posted

Mean

Standard Deviation

minutes

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Secondary

Total Number of RF Ablations Per Procedure

Total number of RF ablations per procedure at index procedure

Subjects with measure available.

Posted

Mean

Standard Deviation

counts

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants	OG000

Secondary

Total Fluid Infused Through the Ablation Catheter (mL)

Total fluid infused through the assigned ablation catheter (mL) at index procedure

Subjects with measure available.

Posted

Mean

Standard Deviation

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants	OG000

Secondary

Total Fluoroscopy Time (Minutes)

Total fluoroscopy time (minutes) at index procedure

Subjects with measure available.

Posted

Mean

Standard Deviation

minutes

Index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants	OG000

Secondary

Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period

Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period

Intention-to-treat population: all randomized subjects are included in this analysis.

Posted

Count of Participants

Participants

3-12 months after index ablation procedure

ID	Title	Description
OG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
OG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected243 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG00014 events10 affected239 at risk EG0013 events3 affected243 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected239 at risk EG0016 events6 affected243 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected243 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Cardiac perforation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected243 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected243 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Pericardial effusion	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected243 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected243 at risk
Chest discomfort	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected239 at risk EG0012 events2 affected243 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Appendicitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Colonic abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Diverticulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Cranial nerve injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Postoperative hypotension	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0015 events5 affected243 at risk
Venous injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Haemochromatosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected243 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected243 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Dizziness postural	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
IVth nerve paralysis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Phrenic nerve paralysis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Presyncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Sciatica	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Seizure like phenomena	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0011 events1 affected243 at risk
Device pacing issue	Product Issues	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Renal disorder	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Renal failure	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected243 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Angioplasty	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Arthrodesis	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Colostomy	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk
Knee operation	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Haemorrhage	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected243 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected243 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected243 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected239 at risk EG0010 events0 affected243 at risk
Pericardial effusion	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected239 at risk EG0013 events3 affected243 at risk
Pericarditis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0011 events1 affected243 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events3 affected243 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events4 affected243 at risk
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0013 events3 affected243 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0015 events4 affected243 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0013 events3 affected243 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0006 events6 affected239 at risk EG0013 events3 affected243 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected239 at risk EG0013 events3 affected243 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0012 events2 affected243 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected239 at risk EG0014 events4 affected243 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0014 events4 affected243 at risk
Haematoma	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0016 events6 affected243 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
BG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DiamondTemp Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	0	239	34	239	32	239
EG001	TactiCath Quartz Ablation Catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	0	243	43	243	41	243