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Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT) (PRECEPT)

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ClinicalTrials.gov Identifier: NCT02817776
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : May 3, 2018
Sponsor:
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 Phase 3

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 RF ablation procedures.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 367 participants
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 Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : May 6, 2019
Estimated Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)).

  2. 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


Secondary Outcome Measures :
  1. Acute Procedural Success [ Time Frame: Immediate post-procedure ]
    Acute procedural success is defined as confirmation of entrance block in all PVs.

  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.
    • 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.

  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 ]
    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
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 PCI)
  4. 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 LA thrombus on imaging
  8. LA size > 50 mm (parasternal long axis view)
  9. 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 TIA) within the past 12 months (365 days)
  14. Rheumatic Heart Disease
  15. Uncontrolled heart failure or 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 ICD/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 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 ClinicalTrials.gov identifier (NCT number): NCT02817776


  Show 30 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT02817776     History of Changes
Other Study ID Numbers: STSF-159
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Biosense Webster, Inc.:
Interventional
Radiofrequency Ablation
Persistent Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes