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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06223789




Registration number
NCT06223789
Ethics application status
Date submitted
16/01/2024
Date registered
25/01/2024
Date last updated
23/09/2024

Titles & IDs
Public title
VOLT-AF IDE Clinical Study
Scientific title
VOLT-AF IDE Clinical Study
Secondary ID [1] 0 0
ABT-CIP-10514
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Arrhythmia 0 0
Atrial Fibrillation 0 0
Paroxysmal Atrial Fibrillation 0 0
Persistent Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pulsed Field Ablation

Experimental: Volt PFA Catheter Sensor Enabled (SE) -


Treatment: Devices: Pulsed Field Ablation
Pulsed field ablation using the Volt PFA System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
7-days
Primary outcome [2] 0 0
Longterm Effectiveness
Timepoint [2] 0 0
12-months
Secondary outcome [1] 0 0
Symptomatic Effectiveness
Timepoint [1] 0 0
12-months
Secondary outcome [2] 0 0
AAD-Free Effectiveness
Timepoint [2] 0 0
12-months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
435
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Austria
State/province [23] 0 0
Linz
Country [24] 0 0
Belgium
State/province [24] 0 0
Brugge
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Czechia
State/province [27] 0 0
Prague
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Koln
Country [32] 0 0
Germany
State/province [32] 0 0
Lübeck
Country [33] 0 0
Italy
State/province [33] 0 0
Ancona
Country [34] 0 0
Netherlands
State/province [34] 0 0
Utrecht
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06223789
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah Kammer
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jessica Arrett
Address 0 0
Country 0 0
Phone 0 0
(+1) 612-380-8445
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06223789