Catheter ablation for consecutive atrial tachycardia after AF or heart surgery
Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
This trial will test whether a focused, minimal-area catheter ablation guided by ultra-high-density mapping or a standard broader ablation better prevents recurrent atrial tachycardia in people who develop AT after prior atrial fibrillation ablation or cardiac surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evangelical Hospital Düsseldorf Academic / other |
| Locations | 6 sites (Hamburg, Free and Hanseatic City of Hamburg and 5 other locations) |
| Trial ID | NCT05239364 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, randomized trial compares a standard ablation strategy to a minimalized ablation that targets only the clinical atrial tachycardia. Ultra-high-density electroanatomical and high-density mapping techniques will be used to characterize AT mechanisms and guide ablation decisions. Eligible adults must have ECG-documented, stable and map-able AT with a cycle length of at least 200 ms following prior AF ablation or cardiac surgery. The primary outcome is arrhythmia-free survival after the randomized ablation approach.
Who should consider this trial
Good fit: Adults with ECG-documented consecutive atrial tachycardia after prior atrial fibrillation ablation or cardiac surgery and with stable, map-able AT (cycle length ≥ 200 ms) are ideal candidates.
Not a fit: People without prior AF ablation or cardiac surgery, those with unstable or unmappable tachycardia, pregnant women, or patients with contraindications to anticoagulation or significant coagulopathy are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could reduce AT recurrences and the need for repeat procedures while limiting the amount of atrial tissue ablated.
How similar studies have performed: Previous observational and non-randomized studies of post-AF or post-surgical AT ablation show mixed results, and ultra-high-density mapping is promising but lacks robust randomized evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive AT subsequent to prior AF ablation procedure or cardiac surgery * Surface ECG-documentation of AT as primary clinical arrhythmia * ECG indicating stable, map-able AT (stable activation sequence, and CL stability) with cycle length ≥ 200ms Exclusion Criteria: * \< 18 years * No previous atrial fibrillation ablation procedure or cardiac surgery * Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment * History of hemorrhagic diathesis or other coagulopathies * Contraindications for oral anticoagulation * Hyper- or hypothyroidism * Has any condition that would make participation not be in the best interest of the subject
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 5 other locations
- Asklepios St. Georg — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Evangelic Hospital Düsseldorf — Düsseldorf, North Rhine-Westfalia, Germany (Recruiting)
- Vivantes Klinikum Am Urban Berlin — Berlin, Germany (Recruiting)
- Evangelic Hospital Hagen-Haspe — Hagen, Germany (Recruiting)
- Städtisches Klinikum Karlsruhe — Karlsruhe, Germany (Recruiting)
- Universitätsklinikum Schleswig Holstein — Kiel, Germany (Recruiting)
Study contacts
- Principal investigator: Christian Meyer, MD — Evangelic Hospital Düsseldorf
- Study coordinator: Christian Meyer, MD
- Email: christian.meyer@evk-duesseldorf.de
- Phone: 00492119191855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.