VOLT-AF IDE Clinical Study

Atrial Fibrillation Clinical Trial

Official title:

VOLT-AF IDE Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223789
• Other study ID #: ABT-CIP-10514
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: Jessica Arrett
• Phone: (+1) 612-380-8445
• Email: jessica.arrett[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 435
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Pulsed Field Ablation
Pulsed field ablation using the Volt PFA System

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	The Prince Charles Hospital	Chermside
Australia	Monash Health	Clayton
Australia	Royal Melbourne Hospital	Parkville
Austria	A.o. Krankenhaus der Elisabethinen Linz	Linz
Belgium	AZ Sint Jan	Brugge
Belgium	UZ Brussel	Brussels
Canada	McGill University Health Centre General Hospital	Montreal	Quebec
Czechia	Nemocnice Na Homolce	Prague
France	Hopital Pitie Salpetriere	Paris
Germany	Deutsches Herzzentrum der Charite	Berlin
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Medizinische Einrichtungen der Universitat zu Koln	Koln
Germany	Universitatsklinikum Schleswig-Holstein-Campus Lubeck	Lübeck
Italy	Az. Osp. Universitaria Osp. Riuniti Umberto I-Lancisi-Salesi	Ancona
Netherlands	UMC Utrecht	Utrecht
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United Kingdom	St. Bartholomew's Hospital	London
United States	Emory University Hospital	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	Affinity Cardiovascular Specialists, LLC	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Trident Medical Center	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Charlton Memorial Hospital	Fall River	Massachusetts
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Memorial Hermann Hospital	Houston	Texas
United States	Community Heart and Vascular	Indianapolis	Indiana
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Evergreen Health	Kirkland	Washington
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	Banner-University Medical Center	Phoenix	Arizona
United States	California Pacific Medical Center - Van Ness Campus	San Francisco	California
United States	AdventHealth Tampa	Tampa	Florida
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System.	Serious adverse events are defined as: Atrio-esophageal fistula; Cardiac tamponade/perforation; Death; Heart block; Myocardial infarction; Pericarditis; Phrenic nerve injury resulting in permanent diaphragmatic paralysis; Pulmonary edema; Pulmonary vein stenosis; Stroke/cerebrovascular accident; Thromboembolism; Transient ischemic attack; Vagal nerve injury/gastroparesis; Major vascular access complications / major bleeding events; Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)	7-days
Primary	Longterm Effectiveness	Rate of freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, trans-telephonic monitoring (TTM) or Holter monitor after the index ablation procedure through 12 months of follow-up (after a 90-day blanking period following the index ablation procedure).	12-months
Secondary	Symptomatic Effectiveness	Rate of freedom from documented symptomatic AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, trans-telephonic monitoring (TTM) or Holter monitor after the index ablation procedure through 12 months of follow-up (after a 90-day blanking period following the index ablation procedure).	12-months
Secondary	AAD-Free Effectiveness	Rate of freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by protocol-specified 12-lead ECG, trans-telephonic monitoring (TTM) or Holter monitor after the index ablation procedure through 12 months of follow-up off all Class I and III AADs (after a 90-day blanking period following the index ablation procedure)	12-months