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

NCT02817776 | Completed Results FDA Device

• 1 other identifier: STSF-159
• Study Type: interventional
• Target: 381
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Interventional; Radiofrequency Ablation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 (5)

• Acute Procedural Success

  Immediate post-procedure

• 15-Month Single Procedure Success

  15-Month

• Early Onset Serious Adverse Event (SAE)

  7 days

• Peri-Procedural Serious Adverse Event (SAE)

  >7 to 30 days

• Late Onset Serious Adverse Event (SAE)

  >30 days up to 15 months

Study Arms (1)

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

Interventions

THERMOCOOL SMARTTOUCH® SF catheter DEVICE

Radiofrequency Ablation

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:.
• Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
• Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Related Publications (2)

• 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.

  PMID: 33290093 DERIVED

• 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.

  PMID: 32819531 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kendra McInnis
• Organization: Biosense Webster Inc

kmcinnis@its.jnj.com

+1 949 322-8010

Study Officials

• 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

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Larry Chinitz, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

• Saumil Oza, MD

  St. Vincent's

  PRINCIPAL INVESTIGATOR

• Anshul Patel, MD

  Emory University Saint Joseph's Hospital

  PRINCIPAL INVESTIGATOR

• Robert Fishel, MD

  JFK Medical Center

  PRINCIPAL INVESTIGATOR

• William Maddox, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Alexander Mazur, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Daniel Melby, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

• Christopher Liu, MD

  New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Kenneth Ellenbogen, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Chad Brodt, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Laurent Macle, MD

  Montreal Heart

  PRINCIPAL INVESTIGATOR

• Philip Gentlesk, MD

  Sentara Heart Hospital

  PRINCIPAL INVESTIGATOR

• James B Deville, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

• Charles Athill, MD

  San Diego Cardiac Center

  PRINCIPAL INVESTIGATOR

• Craig Delaughter, MD

  Texas Health Heart & Vascular

  PRINCIPAL INVESTIGATOR

• Marwan Bahu, MD

  Phoenix Cardiovascular Research Group

  PRINCIPAL INVESTIGATOR

• Jose Osorio, MD

  Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)

  PRINCIPAL INVESTIGATOR

• Marc Deyell, MD

  St. Paul

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: February 4, 2025
• Results First Posted: January 12, 2021

Record last verified: 2025-01