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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03650556
Other study ID # ABT-CIP-10239
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2018
Est. completion date January 11, 2021

Study information

Verified date January 2022
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date January 11, 2021
Est. primary completion date December 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Royal Melbourne Hospital - City Campus Parkville Victoria
United States Emory University Hosptial Atlanta Georgia
United States Texas Cardiac Arrhythmia Austin Texas
United States Johns Hopkins University Hospital Baltimore Maryland
United States University Hospital (UAB) Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States The Cleveland Clinic Foundation Cleveland Ohio
United States Jackson Heart Clinic Jackson Mississippi
United States St. Bernards Jonesboro Arkansas
United States Scripps Health La Jolla California
United States Bryan Heart Lincoln Nebraska
United States Arkansas Heart Hosptial Little Rock Arkansas
United States South Denver Cardiology Associates Littleton Colorado
United States Jersey Shore University Medical Center Neptune New Jersey
United States Ochsner Medical Center New Orleans Louisiana
United States New York University Hospital New York New York
United States Florida Hospital Orlando Florida
United States The Heart Hospital Baylor Plano Plano Texas
United States Sequoia Hospital Redwood City California
United States Barnes-Jewish Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Subjects With a Device and/or Procedure-related SAE. 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. Within 7 days of initial or repeat procedure performed =180 days of initial procedure
Primary Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. 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
15 months
Secondary Acute Procedural Success Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins Immediate post procedure
Secondary 15-month Success Off of Antiarrhythmic Drugs 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 months
Secondary 15 Month Single Procedure Success 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. 15 months
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