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

• ClinicalTrials.gov Identifier: NCT02817776
• Recruitment Status: Completed
• First Posted: June 29, 2016
• Results First Posted: January 12, 2021
• Last Update Posted: January 12, 2021
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

Tracking Information

• First Submitted Date: June 27, 2016
• First Posted Date: June 29, 2016
• Results First Submitted Date: October 30, 2020
• Results First Posted Date: January 12, 2021
• Last Update Posted Date: January 12, 2021
• Actual Study Start Date: June 1, 2016
• Actual Primary Completion Date: June 5, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2020)

• 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
• 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

Original Primary Outcome Measures (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

Current Secondary Outcome Measures (submitted: December 18, 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.
• 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 up to 15 months ]
  Occurrence of Late Onset (>30 days) Serious Adverse Event

Original Secondary Outcome Measures (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: Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Atrial Fibrillation

Intervention

Device: THERMOCOOL SMARTTOUCH® SF catheter

Radiofrequency Ablation

Study Arms

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 *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 2, 2019): 381
• Original Estimated Enrollment (submitted: June 28, 2016): 367
• Actual Study Completion Date: June 5, 2019
• Actual Primary Completion Date: June 5, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02817776
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Biosense Webster, Inc.
• Study Sponsor: Biosense Webster, Inc.
• Collaborators: Not Provided

Investigators

• 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: December 2020