Clinical trial NCT02817776: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Interventional
Radiofrequency Ablation
Persistent Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
timeFrame: 7 days (except as noted in analysis population description)
measure: Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
timeFrame: 15-month follow-up
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Immediate post-procedure
measure: 15-Month Single Procedure Success
timeFrame: 15-Month
measure: Early Onset Serious Adverse Event (SAE)
timeFrame: 7 days
measure: Peri-Procedural Serious Adverse Event (SAE)
timeFrame: >7 to 30 days
measure: Late Onset Serious Adverse Event (SAE)
timeFrame: >30 days up to 15 months
Other outcomes:
Locations:
Study officials:
affiliation: Texas Cardiac Arrhythmia Research
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Francis Marchlinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Bruce Koplan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Walid Saliba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Tristram Banhson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AdventHealth
name: Scott Pollak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Hugh Calkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Moussa Mansour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic Foundation
name: Douglas Packer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Srinivas Dukkipati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Medical Center
name: Larry Chinitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent's
name: Saumil Oza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Saint Joseph's Hospital
name: Anshul Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JFK Medical Center
name: Robert Fishel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: William Maddox, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Alexander Mazur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Allina Health System
name: Daniel Melby, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital
name: Christopher Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Kenneth Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Chad Brodt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart
name: Laurent Macle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sentara Heart Hospital
name: Philip Gentlesk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Research Institute
name: James B Deville, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego Cardiac Center
name: Charles Athill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Health Heart & Vascular
name: Craig Delaughter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phoenix Cardiovascular Research Group
name: Marwan Bahu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)
name: Jose Osorio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul
name: Marc Deyell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.