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

Last updated: April 3, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

PFA Ablation catheter

Clinical Study ID

NCT06676072
ABT-CIP-10520
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentationrequirements are as follows:

  2. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes ofPAF within the 6 months prior to enrollment AND

  3. One electrocardiographically documented PAF episode within 12 months prior toenrollment. 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.

  4. Plans to undergo a catheter ablation procedure due to symptomatic PAF and isrefractory, intolerant, or contraindicated to at least one Class I-IV AAD medication

  5. At least 18 years of age

  6. Able and willing to comply with all trial requirements including pre- procedure,post-procedure, and follow-up testing and requirements

  7. Informed of the nature of the trial, agreed to its provisions, and has providedwritten informed consent as approved by the Institutional Review Board/EthicsCommittee (IRB/EC) of the respective clinical trial site.

Exclusion

Exclusion Criteria:

  1. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)

  2. Arrhythmia due to reversible causes including thyroid disorders, acute alcoholintoxication, electrolyte imbalance, severe untreated sleep apnea, and other majorsurgical 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 withechocardiography or computerized tomography (CT) within 180 days prior to the indexprocedure

  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 ofprocedure

  10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronaryintervention (PCI), or valve or coronary bypass grafting surgery within preceding 90days

  11. Stroke or TIA (transient ischemic attack) within the last 90 days

  12. Heart disease in which corrective surgery is anticipated within 180 days afterprocedure

  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 adequateanticoagulation

  16. Known sensitivity to contrast media (if needed during the procedure) that cannot becontrolled with pre-medication

  17. Previous left atrial surgical or left atrial catheter ablation procedure (includingleft 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 couldpersist 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 orchronic obstructive pulmonary disease) or any other disease or malfunction of thelungs 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 orwithout biventricular pacing function) or planned implant of such a device for anytime during the follow-up period. Presence of an implantable loop recorder isacceptable as long as it is removed prior to insertion of the investigationaldevice.

  32. Patient is currently participating in another clinical trial or has participated ina clinical trial within 30 days prior to screening that may interfere with thisclinical 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 conditionsthat, in the investigator's opinion, could limit the subject's ability toparticipate 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

Study Design

Total Participants: 188
Treatment Group(s): 1
Primary Treatment: PFA Ablation catheter
Phase:
Study Start date:
November 22, 2024
Estimated Completion Date:
April 30, 2026

Study Description

This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.

Connect with a study center

  • KH Wiener Neustadt

    Wiener Neustadt, L Austr 2700
    Austria

    Active - Recruiting

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Dzukija 08661
    Lithuania

    Active - Recruiting

  • Erasmus Medical Center - Thoraxcenter

    Rotterdam, S Holln 3015 CE
    Netherlands

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Arkansas Heart Hospital

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Active - Recruiting

  • South Denver Cardiology Associates PC

    Littleton, Colorado 80120
    United States

    Active - Recruiting

  • Mercy Hospital

    Miami, Florida 33133
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Tallahassee Research Institute

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Piedmont Athens Regional Medical Center

    Athens, Georgia 30606
    United States

    Active - Recruiting

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Providence Hospital

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Heart Rhythm of Mississippi, Research Division

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Bryan Heart Medical Center

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • New York Presbyterian Hospital/Cornell University

    New York, New York 10021
    United States

    Active - Recruiting

  • New York University Hospital

    New York, New York 10016
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia

    Austin, Texas 78705
    United States

    Site Not Available

  • Ocelot Medical Research Group

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Medical City Fort Worth

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Houston Methodist The Woodlands Hospital

    Shenandoah, Texas 77385
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23219
    United States

    Site Not Available

  • The Heart Institute at Virginia Mason

    Seattle, Washington 98111
    United States

    Site Not Available

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