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The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including TGA mode (Temperature Guided Ablation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter | Device | radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieved Acute Procedural Success | Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge. | Day 1 |
| Incidence of Acute Safety | Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs. | 7 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisabethinen Hospital | Linz | Austria | ||||
| OLV Aalst |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31320006 | Derived | Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Purerfellner H. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8. |
| Label | URL |
|---|---|
| Related Info | View source |
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Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects were screened using pre-procedure imaging for the presence of LA thrombus, which was intended to decrease the potential for thromboembolic complications.
A total of 54 subjects were enrolled in the study at 7 sites in Europe. The first subject was enrolled on April 17th, 2018 and the last subject was enrolled on June 20th, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | THERMOCOOL SMARTTOUCH SF-5D Catheter | A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2017 | Sep 20, 2019 |
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| Aalst |
| Belgium |
| AZ Sint-Jan | Bruges | Belgium |
| Jessa Ziekenhuis | Hasselt | Belgium |
| Ceské Budejovice Hospital | České Budějovice | Czechia |
| Na Homolce | Prague | Czechia |
| Ospedale F Miulli | Bari | Italy |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | THERMOCOOL SMARTTOUCH SF-5D Catheter | A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | Participants |
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| 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 | Number of Subjects Achieved Acute Procedural Success | Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge. | Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population. | Posted | Count of Participants | Participants | Day 1 |
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| Primary | Incidence of Acute Safety | Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs. | Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population. | Posted | Count of Participants | Participants | 7 days post-procedure |
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3 months post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | THERMOCOOL SMARTTOUCH SF-5D Catheter | A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including temperature guided ablation mode. | 0 | 52 | 4 | 52 | 32 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA version 19.0 | Systematic Assessment |
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| Diverticulum gastric | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Erosive oesophagitis | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Gastric disorder | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Oesophageal disorder | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Oesophageal mucosa erythema | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Oesophageal polyp | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 19.0 | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
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| Duodenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
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There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Macours / Clinical Research Director | Johnson and Johnson Medical NV/SA | +32 2 746 35 27 | nmacours1@its.jnj.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2018 | Sep 20, 2019 | SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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