Safety and Effectiveness of STSF Catheter Evaluated for T... | NCT02817776

NCT02817776

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.	Device: THERMOCOOL SMARTTOUCH® SF catheter

Name	Type	Description	Arm Group Labels	Other Names
THERMOCOOL SMARTTOUCH® SF catheter	Device	Radiofrequency Ablation	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days	The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: Death Atrio-esophageal fistula* Cardiac Tamponade*+/Perforation+ Myocardial infarction (MI) Stroke / Cerebrovascular accident (CVA) †, †† Thromboembolism Transient Ischemic Attack Diaphragmatic paralysis Pneumothorax Heart block PV stenosis Pulmonary edema (Respiratory Insufficiency) Pericarditis Major Vascular access complication / bleeding	7 days (except as noted in analysis population description)
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up	The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: Acute Procedural Failure Non-Study Catheter Failure Repeat Ablation Failure AAD Failure Surgical Failure	15-month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Acute Procedural Success	Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.	Immediate post-procedure
15-Month Single Procedure Success	The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.
1. Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
2. Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
3. 24-hour Holter within 90 days of the ablation procedure showing continuous AF
Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
Age 18 years or older.
Signed Patient Informed Consent Form (ICF).
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
Previous surgical or catheter ablation for atrial fibrillation
Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)
Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
Any carotid stenting or endarterectomy
Documented left atrial (LA) thrombus on imaging
LA size > 50 mm (parasternal long axis view)
Left ventricular ejection fraction (LVEF) < 40%
Contraindication to anticoagulation (heparin or warfarin)
History of blood clotting or bleeding abnormalities
MI within the past 2 months (60 days)
Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)
Rheumatic Heart Disease
Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
Unstable angina
Acute illness or active systemic infection or sepsis
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Diagnosed atrial myxoma.
Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D).
Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
Enrollment in an investigational study evaluating another device, biologic, or drug.
Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
Presence of any other condition that precludes appropriate vascular access.
Life expectancy less than 12 months

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Andrea Natale, MD	Texas Cardiac Arrhythmia Research	Principal Investigator
Francis Marchlinski, MD	University of Pennsylvania	Principal Investigator
Bruce Koplan, MD	Brigham and Women's Hospital	Principal Investigator
Walid Saliba, MD	The Cleveland Clinic	Principal Investigator
Tristram Banhson, MD	Duke University	Principal Investigator
Scott Pollak, MD	AdventHealth	Principal Investigator
Hugh Calkins, MD	Johns Hopkins University	Principal Investigator
Moussa Mansour, MD	Massachusetts General Hospital	Principal Investigator
Douglas Packer, MD	Mayo Clinic Foundation	Principal Investigator
Srinivas Dukkipati, MD

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33290093	Derived	Natale A, Calkins H, Osorio J, Pollak SJ, Melby D, Marchlinski FE, Athill CA, Delaughter C, Patel AM, Gentlesk PJ, DeVille B, Macle L, Ellenbogen KA, Dukkipati SR, Reddy VY, Mansour M; PRECEPT Investigators. Positive Clinical Benefit on Patient Care, Quality of Life, and Symptoms After Contact Force-Guided Radiofrequency Ablation in Persistent Atrial Fibrillation: Analyses From the PRECEPT Prospective Multicenter Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e008867. doi: 10.1161/CIRCEP.120.008867. Epub 2020 Dec 8.
32819531

IPD Sharing Statement Module

No data available

No data is available for this block.

ID	Title	Description
FG000	Treatment Group	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000381 subjects33 excluded prior to procedure. 348 had study catheter inserted (Safety Population)
COMPLETED		FG000293 subjects
NOT COMPLETED		FG00088 subjects

Type	Comment	Reasons
Excluded		FG00033 subjects
Lost to Follow-up		FG00020 subjects
Withdrawal by Subject		FG00033 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Treatment Group	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days

The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below:

Death
Atrio-esophageal fistula*
Cardiac Tamponade**+/Perforation+
Myocardial infarction (MI)
Stroke / Cerebrovascular accident (CVA) †, ††
Thromboembolism
Transient Ischemic Attack
Diaphragmatic paralysis
Pneumothorax
Heart block
PV stenosis*
Pulmonary edema (Respiratory Insufficiency)
Pericarditis
Major Vascular access complication / bleeding

The safety population was used as the primary analysis population. Subjects with missing 3-month follow-up were excluded from the primary analysis unless the subjects experienced a Primary AE prior to the 3-month visit post-procedure. PV stenosis and AE fistula that occurred > 1 week and cardiac tamponade/perforation that occurred up to 30 days post ablation were also deemed Primary AEs.

Posted

Number

Percentage of participants

7 days (except as noted in analysis population description)

ID	Title

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Group	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cardiac Tamponade	Cardiac disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Kendra McInnis	Biosense Webster Inc	+1 949 322-8010		kmcinnis@its.jnj.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 31, 2018	Oct 30, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	May 1, 2018	Oct 30, 2020	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D001281	Atrial Fibrillation

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

EG0005 events5 affected348 at risk