VOLT-AF First-In-Human Study - VOLT-AF

Abbott Medical0 sites7 target enrollmentStarted: TBDLast updated: April 9, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Withdrawn
Sponsor: Abbott Medical
Enrollment: 7

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Ages: 18 to 99 (—)

Inclusion Criteria

•1. Documented symptomatic PAF or PersAF. Documentation requirements are as
•Paroxysmal:
•Physician*s note indicating recurrent self-terminating AF AND
•One electrocardiographically documented PAF episodes within 12 months.
•Documented evidence of the PAF episode must either be continuous AF on a
•12-lead ECG or include at least 30 seconds of AF from another ECG device.
•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 the procedure, showing continuous AF,
•Two electrocardiograms (from any form of rhythm monitoring) showing
•continuous AF:
•o that are taken at least 7 days apart but less than 12 months apart
•o 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
•with the most recent electrocardiogram within 180 days of enrollment.
•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 that is
•refractory or intolerant to at least one Class I or III antiarrhythmic
•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

•A patient will be excluded from enrollment in the clinical trial if he/she
•meets any of the following criteria:
•1. Previously diagnosed long-standing persistent atrial fibrillation (AF
•greater than 1 year in
•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. Participant known to require ablation beyond PVI prior to initiating the
•index procedure
•4. Known presence of cardiac thrombus
•5. Left atrial diameter >= 5.5 cm (anteroposterior diameter)
•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
•10. Patients who have had a ventriculotomy or atriotomy within the preceding 28
•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 sate
•16. Contraindication to long term anti-thromboembolic therapy
•17. Patient unable to receive heparin or an acceptable alternative to achieve
•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 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
+15 more not shown

Investigators

Sponsor

Abbott Medical

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