A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:

Completed · Not applicable

Conditions studied: Atrial Fibrillation (AF), Atrial Arrhythmia, Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation

In brief

The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Key facts

Study ID: NCT06676072
Run by: Abbott Medical Devices
People needed: 188
Starts: 2024-11-22
Expected to finish: 2026-04-13
Last updated by the study team: 2026-06-01

Who can join

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

You may qualify if…

Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows:
Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
One electrocardiographically documented PAF episode within 12 months prior to enrollment.
NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
At least 18 years of age
Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and requirements
Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

You may not qualify if…

Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
Known presence of cardiac thrombus
Left atrial diameter (LAD) > or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
Left ventricular ejection fraction (LVEF) < or equal to 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure
New York Heart Association (NYHA) class III or IV heart failure
Body mass index > or equal to 40 kg/m2
Pregnant or nursing
Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure
Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
Stroke or TIA (transient ischemic attack) within the last 90 days
Heart disease in which corrective surgery is anticipated within 180 days after procedure
History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti- coagulant state
Contraindication to long-term anti-thromboembolic therapy
Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)
Plans to have an LAA closure device implanted during the follow-up period
Presence of any condition that precludes appropriate vascular access
Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
Previous tricuspid or mitral valve replacement or repair
Patients with prosthetic valves
Patients with a myxoma
Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
Stent, constriction, or stenosis in a pulmonary vein

Where it is running

HonorHealth — Scottsdale, Arizona, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
Stanford University Medical Center — Stanford, California, United States
South Denver Cardiology Associates PC — Littleton, Colorado, United States
HCA Florida Mercy Hospital — Miami, Florida, United States
AdventHealth Orlando — Orlando, Florida, United States
Tallahassee Research Institute — Tallahassee, Florida, United States
Piedmont Athens Regional Medical Center — Athens, Georgia, United States
Loyola University Medical Center — Maywood, Illinois, United States
Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
University of Michigan Medical Center — Ann Arbor, Michigan, United States
Henry Ford Providence Southfield Hospital — Southfield, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
The Heart Rhythm Center of MS — Gulfport, Mississippi, United States
Bryan Heart Medical Center — Lincoln, Nebraska, United States
NYU Langone Health — New York, New York, United States
New York Presbyterian Hospital/Cornell University — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Tristar Centennial Medical Center — Nashville, Tennessee, United States
Vanderbilt Heart & Vascular Institute — Nashville, Tennessee, United States
Texas Cardiac Arrhythmia — Austin, Texas, United States
Ocelot Medical Research Group — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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