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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650556
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : April 27, 2022
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 28, 2018
Results First Submitted Date  ICMJE January 18, 2022
Results First Posted Date  ICMJE April 27, 2022
Last Update Posted Date April 27, 2022
Actual Study Start Date  ICMJE September 28, 2018
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • Rate of Subjects With a Device and/or Procedure-related SAE. [ Time Frame: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure ]
    Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.
  • Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. [ Time Frame: 15 months ]
    The following events were considered a failure for AF/AFL/AT recurrence:
    • If AF/AFL/AT recurrence (>30 second episode) occurred at any time after the therapy consolidation period (>180 days after the initial procedure), or
    • If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a >30 second AF/AFL/AT episode, or
    • If the subject required a second repeat procedure at any time after the initial procedure, or
    • If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or
    • If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or
    • If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2018)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • Acute Procedural Success [ Time Frame: Immediate post procedure ]
    Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
  • 15-month Success Off of Antiarrhythmic Drugs [ Time Frame: 15 months ]
    Percent 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.
  • 15 Month Single Procedure Success [ Time Frame: 15 months ]
    Percent 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 was deemed an effectiveness failure in this analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2018)
  • Acute Procedural Success [ Time Frame: Immediate post procedure ]
    Acute procedural success is defined as confirmation of entrance block in all pulmonary veins
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Official Title  ICMJE Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF
Study Arms  ICMJE Experimental: Ablation
Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).
Intervention: Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
224
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2018)
158
Actual Study Completion Date  ICMJE January 11, 2021
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03650556
Other Study ID Numbers  ICMJE ABT-CIP-10239
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott Medical Devices
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP