Clinical trial NCT03650556: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of Subjects With a Device and/or Procedure-related SAE.
timeFrame: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure
measure: Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.
timeFrame: 15 months
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Immediate post procedure
measure: 15-month Success Off of Antiarrhythmic Drugs
timeFrame: 15 months
measure: 15 Month Single Procedure Success
timeFrame: 15 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital (UAB)
state: Alabama
city: Jonesboro
country: United States
facility: St. Bernards
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hosptial
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hosptial
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital - City Campus
state: Victoria
Study officials:
References: