Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

Atrial Fibrillation Clinical Trial

— RESTART  

Official title:

Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05477147
• Other study ID #: CLIPL-01-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Volta Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

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

8. Inadequate anticoagulation as defined in the inclusion criteria

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Catheter Ablation
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst
France	Hôpital Privé Jacques Cartier	Massy
France	Clinique Pasteur	Toulouse
United States	The Ohio State University	Columbus	Ohio
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	Ascension St. Vincent's Hospital	Jacksonville	Florida
United States	Northwell Health System	New York	New York
United States	Kansas City Cardiac Arrhythmia Research LLC	Overland Park	Kansas
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Volta Medical

Countries where clinical trial is conducted

United States,  Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from AF	Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure	1 year