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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.
 
ClinicalTrials.gov Identifier: NCT02817776
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date June 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • 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)).
  • Incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • Acute Procedural Success [ Time Frame: Immediate post-procedure ]
    Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.
  • 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.
    • The 15-month single procedure success is defined as freedom from documented symptomatic 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.
  • Early Onset Serious Adverse Event (SAE) [ Time Frame: 7 days ]
    • Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event
  • Peri-Procedural Serious Adverse Event (SAE) [ Time Frame: >7 to 30 days ]
    Peri-Procedural (>7 to 30 days) Serious Adverse Event
  • Late Onset Serious Adverse Event (SAE) [ Time Frame: >30 days ]
    Occurrence of Late Onset (>30 days) Serious Adverse Event
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Acute Procedural Success [ Time Frame: Immediate post-procedure ]
    Acute procedural success is defined as confirmation of entrance block in all PVs.
  • 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.
    • The 15-month single procedure success is defined as freedom from documented symptomatic 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.
  • Early Onset Serious Adverse Event (SAE) [ Time Frame: 7 days ]
    • Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event
  • Peri-Procedural Serious Adverse Event (SAE) [ Time Frame: >7 to 30 days ]
    Peri-Procedural (>7 to 30 days) Serious Adverse Event
  • Late Onset Serious Adverse Event (SAE) [ Time Frame: >30 days ]
    Occurrence of Late Onset (>30 days) Serious Adverse Event
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
Official Title  ICMJE Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: THERMOCOOL SMARTTOUCH® SF catheter
Radiofrequency Ablation
Study Arms  ICMJE Experimental: Treatment group
Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Intervention: Device: THERMOCOOL SMARTTOUCH® SF catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
381
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
367
Actual Study Completion Date  ICMJE June 5, 2019
Actual Primary Completion Date June 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02817776
Other Study ID Numbers  ICMJE STSF-159
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biosense Webster, Inc.
Study Sponsor  ICMJE Biosense Webster, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Biosense Webster, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP