Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: THERMOCOOL SMARTTOUCH® SF catheter

• Registration Number: NCT02817776
• Lead Sponsor: Biosense Webster, Inc.

Brief Summary

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Detailed Description

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Disposition First Submitted: 2020-05-28
• Disposition First Submitted QC: 2020-07-10
• Disposition First Posted: 2020-07-14
• Results First Submitted: 2020-10-30
• Results First Submitted QC: 2020-12-18
• Results First Posted: 2021-01-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

Inclusion Criteria

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

1. 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

2. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.

3. Age 18 years or older.

4. Signed Patient Informed Consent Form (ICF).

5. 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:

1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
2. Previous surgical or catheter ablation for atrial fibrillation
3. Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
4. Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)
5. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
6. Any carotid stenting or endarterectomy
7. Documented left atrial (LA) thrombus on imaging
8. LA size > 50 mm (parasternal long axis view)
9. Left ventricular ejection fraction (LVEF) < 40%
10. Contraindication to anticoagulation (heparin or warfarin)
11. History of blood clotting or bleeding abnormalities
12. MI within the past 2 months (60 days)
13. Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)
14. Rheumatic Heart Disease
15. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
16. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
17. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
18. Unstable angina
19. Acute illness or active systemic infection or sepsis
20. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
21. Diagnosed atrial myxoma.
22. Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D).
23. 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.
24. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)
25. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
27. Enrollment in an investigational study evaluating another device, biologic, or drug.
28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
29. Presence of any other condition that precludes appropriate vascular access.
30. Life expectancy less than 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days	7 days (except as noted in analysis population description)	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
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up	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

Secondary Outcome Measures

Name	Time	Method
Acute Procedural Success	Immediate post-procedure	Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.
Late Onset Serious Adverse Event (SAE)	>30 days up to 15 months	Occurrence of Late Onset (\>30 days) Serious Adverse Event
15-Month Single Procedure Success	15-Month	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.
Peri-Procedural Serious Adverse Event (SAE)	>7 to 30 days	Peri-Procedural (\>7 to 30 days) Serious Adverse Event
Early Onset Serious Adverse Event (SAE)	7 days	Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event

Trial Locations

Locations (30)

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Health Heart & Vascular Hospital; 🇺🇸 Arlington, Texas, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

New York University; 🇺🇸 New York, New York, United States

Phoenix Cardiovascular Research Group; 🇺🇸 Phoenix, Arizona, United States

JFK Medical Center; 🇺🇸 Atlantis, Florida, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

St Vincent's Medical Center; 🇺🇸 Jacksonville, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Montreal Heart Institute; 🇨🇦 Montreal, Quabec, Canada

Texas Cardiac Arrhythmia Research; 🇺🇸 Austin, Texas, United States

Baylor Research Institute; 🇺🇸 Plano, Texas, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Sentara Heart Hospital; 🇺🇸 Norfolk, Virginia, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Mayo Clinic Foundation; 🇺🇸 Rochester, Minnesota, United States

Montefiore Hospital; 🇺🇸 Bronx, New York, United States

St Francis Hospital; 🇺🇸 Roslyn, New York, United States

Affinity Cardiovascular Specialists (Alabama Cardiovascular Group); 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

New York Presbyterian Hospital - Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

San Diego Cardiac Center; 🇺🇸 San Diego, California, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States