TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Key facts

Study ID

NCT02310100

Run by

Abbott Medical Devices

People needed

178

Starts

2015-01-21

Expected to finish

2021-09-17

Last updated by the study team

2021-10-12

Who can join

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

You may qualify if…

• Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug
• Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device
• Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
• Patient is 18 years of age or older
• Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
• Patient provides written informed consent prior to enrollment in the study

You may not qualify if…

• Persistent or long-standing persistent atrial fibrillation (AF)
• Patient has had 4 or more cardioversions in the past 12 months.
• Active systemic infection
• Presence of implantable cardiac defibrillator (ICD)
• Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
• Left atrial diameter > 5.0 cm
• Left ventricular ejection fraction < 35%
• New York Heart Association (NYHA) class III or IV
• Previous left atrial ablation procedure, either surgical or catheter ablation
• Patient has had a left atrial surgical procedure or incision with resulting scar
• Previous tricuspid or mitral valve replacement or repair
• Heart disease in which corrective surgery is anticipated within 6 months
• Bleeding diathesis or suspected pro coagulant state
• Contraindication to long term antithromboembolic therapy
• Presence of any condition that precludes appropriate vascular access
• Renal failure requiring dialysis
• Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• Contraindication to computed tomography and magnetic resonance angiography
• Severe 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 severe chronic symptoms
• Positive pregnancy test results for female patients of childbearing potential
• Patient has other anatomic or co morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results
• Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this study
• Patient is unlikely to survive the protocol follow up period of 12 months

Where it is running

• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• Cardiology Consultants of East Michigan — Flint, Michigan, United States
• Providence Hospital — Southfield, Michigan, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• Mount Sinai Hospital — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Providence Heart and Vascular Institute — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Centennial Medical Center — Nashville, Tennessee, United States
• Texas Cardiac Arrhythmia — Austin, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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