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

NCT ID: NCT02817776

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-06-05

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

THERMOCOOL SMARTTOUCH® SF catheter

Intervention Type: DEVICE

Radiofrequency Ablation

Interventions

THERMOCOOL SMARTTOUCH® SF catheter

Radiofrequency Ablation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research

Francis Marchlinski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Bruce Koplan, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Walid Saliba, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Tristram Banhson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Scott Pollak, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Hugh Calkins, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Moussa Mansour, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Douglas Packer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Foundation

Srinivas Dukkipati, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Larry Chinitz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Saumil Oza, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's

Anshul Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Saint Joseph's Hospital

Robert Fishel, MD

Role: PRINCIPAL_INVESTIGATOR

JFK Medical Center

William Maddox, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Alexander Mazur, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Daniel Melby, MD

Role: PRINCIPAL_INVESTIGATOR

Allina Health System

Christopher Liu, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital

Kenneth Ellenbogen, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Chad Brodt, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Laurent Macle, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart

Philip Gentlesk, MD

Role: PRINCIPAL_INVESTIGATOR

Sentara Heart Hospital

James B Deville, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Research Institute

Charles Athill, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Cardiac Center

Craig Delaughter, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Health Heart & Vascular

Marwan Bahu, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Cardiovascular Research Group

Jose Osorio, MD

Role: PRINCIPAL_INVESTIGATOR

Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)

Marc Deyell, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul

References

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.

Reference Type: DERIVED

PMID: 33290093 (View on PubMed)

Mansour M, 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, Natale A. Persistent Atrial Fibrillation Ablation With Contact Force-Sensing Catheter: The Prospective Multicenter PRECEPT Trial. JACC Clin Electrophysiol. 2020 Aug;6(8):958-969. doi: 10.1016/j.jacep.2020.04.024.

Reference Type: DERIVED

PMID: 32819531 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STSF-159

Identifier Type: -

Identifier Source: org_study_id