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

Atrial Fibrillation Clinical Trial

— PRECEPT  

Official title:

Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817776
• Other study ID #: STSF-159
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: June 5, 2019

Study information

• Verified date: December 2020
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• THERMOCOOL SMARTTOUCH® SF catheter
Radiofrequency Ablation

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quabec
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	Texas Health Heart & Vascular Hospital	Arlington	Texas
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Hospital	Bronx	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	St Vincent's Medical Center	Jacksonville	Florida
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Mount Sinai School of Medicine	New York	New York
United States	New York Presbyterian Hospital - Weill Cornell Medical Center	New York	New York
United States	New York University	New York	New York
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	Florida Hospital	Orlando	Florida
United States	Stanford University School of Medicine	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	Baylor Research Institute	Plano	Texas
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic Foundation	Rochester	Minnesota
United States	St Francis Hospital	Roslyn	New York
United States	San Diego Cardiac Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	7 days (except as noted in analysis population description)
Primary	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	Acute Procedural Success	Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.	Immediate post-procedure
Secondary	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.	15-Month
Secondary	Early Onset Serious Adverse Event (SAE)	Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event	7 days
Secondary	Peri-Procedural Serious Adverse Event (SAE)	Peri-Procedural (>7 to 30 days) Serious Adverse Event	>7 to 30 days
Secondary	Late Onset Serious Adverse Event (SAE)	Occurrence of Late Onset (>30 days) Serious Adverse Event	>30 days up to 15 months