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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: THERMOCOOL SMARTTOUCH® SF catheter

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 Type: Interventional
• Enrollment (Actual): 381
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, BC V6Z 1Y6
      • St. Paul's Hospital
  • Quabec
    • Montreal, Quabec, Canada, QC H1T 1C8
      • Montreal Heart Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35205
      • Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Phoenix Cardiovascular Research Group
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University School of Medicine
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
  • Florida
    • Atlantis, Florida, United States, 92201
      • JFK Medical Center
    • Jacksonville, Florida, United States, 32204
      • St Vincent's Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Foundation
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Hospital
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10003
      • New York University
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital - Weill Cornell Medical Center
    • Roslyn, New York, United States, 11576
      • St Francis Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Health Heart & Vascular Hospital
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
    • Plano, Texas, United States, 75204
      • Baylor Research Institute
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Heart Hospital
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.	Device: THERMOCOOL SMARTTOUCH® SF catheter; Radiofrequency Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	15-Month
Early Onset Serious Adverse Event (SAE)	Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event	7 days
Peri-Procedural Serious Adverse Event (SAE)	Peri-Procedural (>7 to 30 days) Serious Adverse Event	>7 to 30 days
Late Onset Serious Adverse Event (SAE)	Occurrence of Late Onset (>30 days) Serious Adverse Event	>30 days up to 15 months

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: William Maddox, MD, University of Alabama at Birmingham; Principal Investigator: Walid Saliba, MD, The Cleveland Clinic; Principal Investigator: Francis Marchlinski, MD, University of Pennsylvania; Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research; Principal Investigator: Bruce Koplan, MD, Brigham and Women's Hospital; Principal Investigator: Tristram Banhson, MD, Duke University; Principal Investigator: Scott Pollak, MD, AdventHealth; Principal Investigator: Douglas Packer, MD, Mayo Clinic Foundation; 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: 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, Montréal Heart; Principal Investigator: Philip Gentlesk, MD, Sentara Heart Hospital; Principal Investigator: James B Deville, MD, Baylor Research Institute; Principal Investigator: Craig Delaughter, MD, Texas Health Heart & Vascular; Principal Investigator: Jose Osorio, MD, Affinity Cardiovascular Specialists (Alabama Cardiovascular Group); Principal Investigator: Marc Deyell, MD, St. Paul

Publications and helpful links

General Publications

• 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. Erratum In: Circ Arrhythm Electrophysiol. 2021 May;14(5):e000076.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Interventional; Radiofrequency Ablation; Persistent Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STSF-159

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes