Search / Trial NCT06223789

VOLT-AF IDE Clinical Study

Launched by ABBOTT MEDICAL DEVICES · Jan 16, 2024

Trial Information

Current as of October 08, 2024

Unknown status

Keywords

Atrial Arrhythmia Paroxysmal Af Pfa Persistent Atrial Fibrillation Pulsed Field Ablation

Description

This is a pre-market, prospective, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF).

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
  • Paroxysmal:
  • * 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.
  • Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
  • * Physician's note, AND either
  • * 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR
  • * Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
  • * That are taken at least 7 days apart but less than 12 months apart
  • * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
  • * The most recent electrocardiogram must be within 180 days of 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 AF from another ECG device.
  • 2. Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF 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:
  • 1. Previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
  • 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. Patient known to require ablation beyond PVI at the time of consent.
  • 4. Known presence of cardiac thrombus
  • 5. Left atrial diameter ≥ 5.5 cm (anteroposterior diameter) within 180 days of index procedure.
  • 6. Left ventricular ejection fraction \< 35% as assessed with echocardiography within 180 days of index procedure
  • 7. New York Heart Association (NYHA) class III or IV heart failure
  • 8. Body mass index \> 40 kg/m2
  • 9. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
  • 10. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure,
  • 11. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
  • 12. Unstable angina
  • 13. Stroke or TIA (transient ischemic attack) within the last 90 days
  • 14. Heart disease in which corrective surgery is anticipated within 180 days after procedure
  • 15. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
  • 16. Contraindication to long term anti-thromboembolic therapy
  • 17. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
  • 18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
  • 19. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
  • 20. Presence of any condition that precludes appropriate vascular access
  • 21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
  • 22. Previous tricuspid or mitral valve replacement or repair
  • 23. Patients with prosthetic valves
  • 24. Patients with a myxoma
  • 25. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
  • 26. Stent, constriction, or stenosis in a pulmonary vein
  • 27. Rheumatic heart disease
  • 28. Hypertrophic cardiomyopathy
  • 29. Diagnosed with amyloidosis or atrial amyloidosis
  • 30. Active systemic infection
  • 31. Renal failure requiring dialysis
  • 32. 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
  • 33. 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.
  • 34. Presence of an implanted LAA closure device or plans to have an LAA closure device implanted during the follow-up period
  • 35. 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
  • 36. Unlikely to survive the protocol follow up period of 12 months
  • 37. 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.
  • 38. Individuals without legal authority
  • 39. Individuals unable to read or write

About Abbott Medical Devices

Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.

Locations

Columbus, Ohio, United States

Boston, Massachusetts, United States

Columbus, Ohio, United States

Chicago, Illinois, United States

Los Angeles, California, United States

Norfolk, Virginia, United States

Washington, District Of Columbia, United States

Doylestown, Pennsylvania, United States

Orlando, Florida, United States

Falls Church, Virginia, United States

Paris, , France

Houston, Texas, United States

Cleveland, Ohio, United States

Atlanta, Georgia, United States

New York, New York, United States

Kansas City, Missouri, United States

Parkville, , Australia

London, , United Kingdom

Baltimore, Maryland, United States

Austin, Texas, United States

Little Rock, Arkansas, United States

Utrecht, , Netherlands

Adelaide, , Australia

Brugge, , Belgium

Littleton, Colorado, United States

Loveland, Colorado, United States

Hamburg, , Germany

Indianapolis, Indiana, United States

Brussels, , Belgium

Valencia, , Spain

Prague, , Czechia

Chermside, , Australia

Kirkland, Washington, United States

Charleston, South Carolina, United States

San Francisco, California, United States

Fall River, Massachusetts, United States

Overland Park, Kansas, United States

New York, New York, United States

Clayton, , Australia

Tampa, Florida, United States

Phoenix, Arizona, United States

Oklahoma City, Oklahoma, United States

Birmingham, Alabama, United States

Linz, , Austria

Atlanta, Georgia, United States

Montreal, Quebec, Canada

Berlin, , Germany

Koln, , Germany

Lübeck, , Germany

Ancona, , Italy

Kansas City, Missouri, United States

London, , United Kingdom

Kansas City, Missouri, United States

London, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0