A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
NCT ID: NCT06676072
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
188 participants
INTERVENTIONAL
2024-11-22
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TactiFlex Ablation catheter
A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and to transmit RF current or PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.
PFA Ablation catheter
Deliver RF and/or PF energy using the TactFlex PFA system
Interventions
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PFA Ablation catheter
Deliver RF and/or PF energy using the TactFlex PFA system
Eligibility Criteria
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Inclusion Criteria
1. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
2. 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.
2. 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
3. At least 18 years of age
4. Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and requirements
5. 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.
Exclusion Criteria
2. 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
3. Known presence of cardiac thrombus
4. Left atrial diameter (LAD) \> or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
5. 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
6. New York Heart Association (NYHA) class III or IV heart failure
7. Body mass index \> or equal to 40 kg/m2
8. Pregnant or nursing
9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure
10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
11. Stroke or TIA (transient ischemic attack) within the last 90 days
12. Heart disease in which corrective surgery is anticipated within 180 days after procedure
13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti- coagulant state
14. Contraindication to long-term anti-thromboembolic therapy
15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)
18. Plans to have an LAA closure device implanted during the follow-up period
19. Presence of any condition that precludes appropriate vascular access
20. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
21. Previous tricuspid or mitral valve replacement or repair
22. Patients with prosthetic valves
23. Patients with a myxoma
24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
25. Stent, constriction, or stenosis in a pulmonary vein
26. Rheumatic heart disease
27. Hypertrophic cardiomyopathy
28. Active systemic infection
29. Renal failure requiring dialysis
30. 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
31. Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device.
32. 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 clinical trial without pre-approval from this study Sponsor
33. Unlikely to survive the protocol follow up period of 12 months
34. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
35. Individuals without legal authority
36. Individuals unable to read or write
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Kammer
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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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
Medical City Fort Worth
Fort Worth, Texas, United States
Houston Methodist The Woodlands Hospital
Shenandoah, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
The Heart Institute at Virginia Mason
Seattle, Washington, United States
KH Wiener Neustadt
Wiener Neustadt, L Austr, Austria
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Dzukija, Lithuania
Erasmus Medical Center - Thoraxcenter
Rotterdam, S Holln, Netherlands
Countries
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Other Identifiers
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ABT-CIP-10520
Identifier Type: -
Identifier Source: org_study_id
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