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Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03650556
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ablation
Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.
Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF




Primary Outcome Measures :
  1. Incidence of device and/or procedure-related SAEs. [ Time Frame: Within 7 days of initial and repeat procedure ]
    1. Incidence of device and/or procedure-related SAEs with onset within 7-days of the ablation procedure.

  2. Freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence. [ Time Frame: Through 15 months ]
    2. Freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence through 15-months.


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

  2. 15-month Success off of Antiarrhythmic Drugs [ Time Frame: 15 months ]
    Proportion of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.

  3. 15 Month Single Procedure Success [ Time Frame: 15 months ]
    Proportion of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time will be deemed an effectiveness failure in this analysis.



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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:

  1. Patient must provide written informed consent prior to any clinical investigation related procedure.
  2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF
  3. Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF
  4. Age 18 years or older
  5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

  1. Continuous AF > 12 months (longstanding persistent AF)
  2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar
  3. Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure
  4. CABG surgery within the 6-months (180-days) prior to the initial procedure
  5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
  6. Any carotid stenting or endarterectomy
  7. Documented or known left atrial thrombus on imaging
  8. Left atrial diameter > 50 mm (parasternal long axis view or by CT)
  9. Left ventricular ejection fraction < 40%
  10. Unable to take anticoagulation medication due to contraindication or intolerance
  11. History of blood clotting or bleeding abnormalities
  12. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure
  13. Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure
  14. Rheumatic heart disease
  15. Uncontrolled heart failure or NYHA functional 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 12-months (365 days) following the initial ablation procedure
  18. Unstable angina at the time of the initial procedure
  19. Acute illness or active systemic infection or sepsis
  20. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause
  21. Diagnosed atrial myxoma
  22. Presence of implanted implantable cardioverter defibrillator (ICD) or 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. Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results
  25. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  26. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure
  27. Presence of any condition that precludes appropriate vascular access or manipulation of catheter
  28. Life expectancy less than 12-months
  29. Body mass index > 40 kg/m2
  30. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  31. Renal failure requiring dialysis
  32. Vulnerable subject
  33. History of atriotomy or ventriotomy
  34. Implanted endocardial left atrial appendage occlusion device

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): NCT03650556


Contacts
Contact: Laura Menck 651-756-2375 laura.menck@abbott.com

Locations
United States, Arkansas
St. Bernards Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Kayla Rubino, LPN       krubino@stbheart.com   
Principal Investigator: Devi Nair, MD         
Arkansas Heart Hosptial Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Molly Kyle         
Contact       marycatherine.faulkner@arheart.com   
Principal Investigator: Monica Lo, MD         
United States, Colorado
South Denver Cardiology Associates Recruiting
Littleton, Colorado, United States, 80120
Contact: Mary Soltau, RN       msoltau@southdenver.com   
Principal Investigator: Sri Sundaram, MD         
United States, Georgia
Emory University Hosptial Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jessica Nelson       Jnels30@emory.edu   
Principal Investigator: David DeLurgio, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Melanie Lunn       mlunn@ochsner.org   
Principal Investigator: Sammy Khatib, MD         
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Jamie Neal       jneal@jacksonheart.com   
Principal Investigator: Judson Colley, MD         
United States, Texas
Texas Cardiac Arrhythmia Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal, RN       dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, MN         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Destiny Barnett       destiny.barnett@bswhealth.org   
Principal Investigator: Adam Shapira, MN         
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03650556     History of Changes
Other Study ID Numbers: ABT-CIP-10239
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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