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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02817776
Recruitment Status : Completed
First Posted : June 29, 2016
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: THERMOCOOL SMARTTOUCH® SF catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days [ Time Frame: 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

  2. Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up [ Time Frame: 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 :
  1. Acute Procedural Success [ Time Frame: Immediate post-procedure ]
    Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.

  2. 15-Month Single Procedure Success [ Time Frame: 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.

  3. Early Onset Serious Adverse Event (SAE) [ Time Frame: 7 days ]
    Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event

  4. Peri-Procedural Serious Adverse Event (SAE) [ Time Frame: >7 to 30 days ]
    Peri-Procedural (>7 to 30 days) Serious Adverse Event

  5. Late Onset Serious Adverse Event (SAE) [ Time Frame: >30 days up to 15 months ]
    Occurrence of Late Onset (>30 days) Serious Adverse Event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02817776

Show Show 30 study locations
Sponsors and Collaborators
Biosense Webster, Inc.
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Biosense Webster, Inc.:
Study Protocol  [PDF] July 31, 2018
Statistical Analysis Plan  [PDF] May 1, 2018

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biosense Webster, Inc. Identifier: NCT02817776    
Other Study ID Numbers: STSF-159
First Posted: June 29, 2016    Key Record Dates
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Biosense Webster, Inc.:
Radiofrequency Ablation
Persistent Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes