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

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03650556

Run by

Abbott Medical Devices

People needed

224

Starts

2018-09-28

Expected to finish

2021-01-11

Last updated by the study team

2022-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must provide written informed consent prior to any clinical investigation related procedure.
• 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
• Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF
• Age 18 years or older
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You may not qualify if…

• Continuous AF > 12 months (longstanding persistent AF)
• 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
• Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure
• CABG surgery within the 6-months (180-days) prior to the initial procedure
• Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
• Any carotid stenting or endarterectomy
• Documented or known left atrial thrombus on imaging
• Left atrial diameter > 50 mm (parasternal long axis view or by CT)
• Left ventricular ejection fraction < 40%
• Unable to take anticoagulation medication due to contraindication or intolerance
• History of blood clotting or bleeding abnormalities
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure
• Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure
• Rheumatic heart disease
• Uncontrolled heart failure or NYHA functional class III or IV
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
• Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365 days) following the initial ablation procedure
• Unstable angina at the time of the initial procedure
• Acute illness or active systemic infection or sepsis
• 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
• Diagnosed atrial myxoma
• Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
• 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
• 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
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period

Where it is running

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

Full record on ClinicalTrials.gov

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