June 27, 2016
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June 29, 2016
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October 30, 2020
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January 12, 2021
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January 12, 2021
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June 1, 2016
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June 5, 2019 (Final data collection date for primary outcome measure)
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- 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
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- 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
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- 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
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- 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
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Not Provided
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Not Provided
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Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
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Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
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This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
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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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Interventional
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Not Applicable
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Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Atrial Fibrillation
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Device: THERMOCOOL SMARTTOUCH® SF catheter
Radiofrequency Ablation
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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
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- 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.
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Completed
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381
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367
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June 5, 2019
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June 5, 2019 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Candidates for this study must meet ALL of the following criteria:
-
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:.
- Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
- Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
- 24-hour Holter within 90 days of the ablation procedure showing continuous AF
- Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
- Age 18 years or older.
- Signed Patient Informed Consent Form (ICF).
- 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:
- Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
- Previous surgical or catheter ablation for atrial fibrillation
- Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
- Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)
- Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- Any carotid stenting or endarterectomy
- Documented left atrial (LA) thrombus on imaging
- LA size > 50 mm (parasternal long axis view)
- Left ventricular ejection fraction (LVEF) < 40%
- Contraindication to anticoagulation (heparin or warfarin)
- History of blood clotting or bleeding abnormalities
- MI within the past 2 months (60 days)
- Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)
- Rheumatic Heart Disease
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
- Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- Unstable angina
- Acute illness or active systemic infection or sepsis
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Diagnosed atrial myxoma.
- Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D).
- 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.
- Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- Enrollment in an investigational study evaluating another device, biologic, or drug.
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- Presence of any other condition that precludes appropriate vascular access.
- Life expectancy less than 12 months
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Canada, United States
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NCT02817776
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STSF-159
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Not Provided
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Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
Yes |
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Not Provided
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Biosense Webster, Inc.
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Same as current
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Biosense Webster, Inc.
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Same as current
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Not Provided
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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 |
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Biosense Webster, Inc.
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December 2020
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