Comparing two methods of ablation for persistent atrial fibrillation

Complex Fractionated Atrial Electrocardiograms (CFAEs) Spatiotemporal Dispersion Guided Ablation Versus Pulmonary Vein Isolation (PVI) Guided Ablation in Persistent Atrial Fibrillation, a Multicenter Randomized Trial

This study is testing which of two different heart procedures works better for helping people with persistent atrial fibrillation stay free of symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Diagram B.V. (Academic / other)
• Drugs / interventions: Radiation
• Locations: 4 sites (Marseille and 3 other locations)
• Trial ID: NCT02696265 on ClinicalTrials.gov

What this trial studies

This study aims to compare the efficacy and safety of two different ablation techniques for treating persistent atrial fibrillation (AF). One method focuses on ablation guided by complex fractionated atrial electrocardiograms and spatiotemporal dispersion, while the other relies on pulmonary vein isolation. Patients will be randomized into two groups to assess which technique leads to better outcomes in terms of AF-free survival. The study will enroll 180 patients across multiple international sites.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with persistent atrial fibrillation who have failed at least one anti-arrhythmic drug.

Not a fit: Patients with longstanding persistent atrial fibrillation or those who have previously undergone surgical or catheter ablation for AF may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with persistent atrial fibrillation, potentially increasing their chances of remaining free from AF.

How similar studies have performed: Other studies have explored similar ablation techniques, but this specific comparison of CFAE/spatiotemporal dispersion guided ablation versus PVI guided ablation is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:

   1. Sustained beyond 7 days but no more than one year.
   2. Or lasting less than 7 days, but longer than 48 hours and necessitating pharmacologic or electrical cardioversion.
2. Documentation of atrial fibrillation on either a 12-lead ECG or transtelephonic monitoring (TTM), or ambulatory holter monitoring or telemetry strip and a physician's note showing continuous AF.
3. Failure of at least one AAD (Class I or III) as evidenced by recurrent symptomatic AF or intolerable side effects of the AAD.
4. Signed Patient Informed Consent Form.
5. Age 18 years or older.
6. Able and willing to comply with all pre- and follow-up testing and requirements.

Exclusion Criteria:

1. Continuous AF \> 12 months (1-Year) (Longstanding Persistent AF).

1. Previous surgical or catheter ablation for atrial fibrillation.
2. Any cardiac surgery within the past 2 months (60 days) (includes PCI).
3. CABG surgery within the past 6 months (180 days).
4. Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
5. Cardioversion refractory (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion).

   1. If a patient does not have documented evidence of being successfully cardioverted (NSR \> 30 secs), the patient must be cardioverted prior to the ablation procedure with the study catheter.
   2. Failure to cardiovert based on the above criteria is considered a screen failure.
6. Documented LA thrombus on imaging.
7. LA size \>50 mm.
8. LVEF \< 30%.
9. Contraindication to anticoagulation (heparin or warfarin).
10. History of blood clotting or bleeding abnormalities.
11. Myocardial infarction within the past 2 months (60 days).
12. Documented thromboembolic event (including TIA) within the past 12 months (365 days).
13. Rheumatic Heart Disease.
14. Uncontrolled heart failure or NYHA function class III or IV.
15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days).
16. Unstable angina.
17. Acute illness or active systemic infection or sepsis.
18. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
19. Diagnosed atrial myxoma.
20. Presence of implanted ICD.
21. Significant severe pulmonary disease, (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
22. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
23. Women who are pregnant (as evidenced by pregnancy test if pre- menopausal).
24. Enrollment in an investigational study evaluating another device, biologic, or drug.
25. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
26. Presence of a condition that precludes vascular access.
27. Life expectancy or other disease processes likely to limit survival to less than 12 months.

Where this trial is running

Marseille and 3 other locations

• Hopital Saint Joseph — Marseille, France (Recruiting)
• CHU de Nice — Nice, France (Not_yet_recruiting)
• Kagoshima University — Kagoshima, Japan (Recruiting)
• Isala — Zwolle, Overijssel, Netherlands (Recruiting)

Study contacts

• Principal investigator: Jaap-Jan J. Smit, MD, PhD — Isala
• Study coordinator: Gery de Jong, PhD

Conditions Chronic Atrial Fibrillation; Atrial Fibrillation; Complex Fractionated Atrial Electrocardiograms; Pulmonary Vein Isolation; Ablation; CFAE/spatiotemporal dispersion guided ablation