Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

NCT ID: NCT05477147

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-17
• Study Completion Date: 2025-09-30

Brief Summary

Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Patients undergoing catheter ablation that qualify after initial screening.

Group Type: EXPERIMENTAL

Catheter Ablation

Intervention Type: DEVICE

Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).

Interventions

Catheter Ablation

Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients 21 years of age or older indicated for redo AF ablation

2. Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF

3. Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure

4. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation

5. Patients must be able and willing to provide written informed consent to participate in the clinical trial

9. LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure

10. Contraindications to anticoagulation (heparin, warfarin or NOAC)

11. Patients who are or may potentially be pregnant

12. Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)

13. Myocardial infarction within the past 2 months (60 days)

14. Previous AV valve surgery

15. Patient diagnosed with hypertrophic cardiomyopathy

16. History of blood clotting or bleeding abnormalities

17. Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)

18. Rheumatic Heart Disease

19. Cardiac Sarcoidosis

20. Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)

21. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)

22. Unstable angina within the past month

23. Acute illness or active systemic infection or sepsis

24. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause

25. Diagnosed atrial myxoma

26. Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)

27. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

28. Enrollment in an investigational study evaluating another device, biologic, or drug

29. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter

30. Life expectancy or other disease processes likely to limit survival to less than 12 months

31. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Exclusion Criteria

1. Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)

2. First AF ablation procedure indication was persistent AF lasting longer than 24 months

3. Long-standing persistent AF recurrence prior to study redo procedure

4. Previous AF ablation using VX1 software

5. Severe obesity (BMI > 50)

6. Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)

7. Patients with AF secondary to an obvious reversible cause

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volta Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grandview Medical Center

Birmingham, Alabama, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Ascension St. Vincent's Hospital

Jacksonville, Florida, United States

Northshore University Health System

Evanston, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Loyola University

Maywood, Illinois, United States

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Northwell Health System

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Houston Methodist Research Institute

Houston, Texas, United States

Inova Fairfax Hospital

Fairfax, Virginia, United States

OLV Aalst

Aalst, , Belgium

Hôpital Privé Jacques Cartier

Massy, , France

Clinique Pasteur

Toulouse, , France

Deutsches Herzzentrum München

München, , Germany

Countries

United States; Belgium; France; Germany

Other Identifiers

CLIPL-01-003

Identifier Type: -

Identifier Source: org_study_id