Long-term evaluation of tailored vs anatomical ablation for persistent atrial fibrillation
Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Volta Medical · NCT06825104
This study is testing if a personalized approach to treating persistent atrial fibrillation works better than the standard method by following patients for up to five years to see how well they stay free from the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 278 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Volta Medical (industry) |
| Locations | 13 sites (Bron and 12 other locations) |
| Trial ID | NCT06825104 on ClinicalTrials.gov |
What this trial studies
The TAILORED-LT study is an extension follow-up of the TAILORED-AF study, focusing on the long-term effectiveness of a tailored ablation strategy that targets spatio-temporal dispersed electrograms combined with pulmonary vein isolation (PVI) compared to the standard anatomical ablation strategy that targets PVI alone. This observational study will follow patients for up to five years to assess their freedom from atrial fibrillation after the initial treatment. Annual follow-ups will be conducted to monitor patient outcomes and any repeat procedures will be at the investigator's discretion. The study utilizes the Volta AF-Xplorer device for the ablation procedures.
Who should consider this trial
Good fit: Ideal candidates are patients who participated in the initial TAILORED-AF study and completed the 12-month follow-up without withdrawal.
Not a fit: Patients who were withdrawn from the TAILORED-AF study or those unable to undergo medical monitoring for various reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes for patients with persistent atrial fibrillation.
How similar studies have performed: Previous studies have shown success with tailored ablation strategies, making this approach promising for further evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who participated in the Tailored AF study * Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study * Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study Exclusion Criteria: * Person deprived of liberty or under guardianship * Person unable to undergo a medical monitoring for geographical, social or psychological reasons
Where this trial is running
Bron and 12 other locations
- CHU Lyon, Hôpital Louis Pradel — Bron, France (NOT_YET_RECRUITING)
- Pôle Santé République — Clermont-Ferrand, France (NOT_YET_RECRUITING)
- Hôpital Saint Philibert — Lomme, France (NOT_YET_RECRUITING)
- Hôpital Saint-Joseph Marseille — Marseille, France (RECRUITING)
- Hôpital Privé Jacques Cartier — Massy, France (NOT_YET_RECRUITING)
- Hôpital Privé du Confluent — Nantes, France (NOT_YET_RECRUITING)
- Polyclinique Saint George — Nice, France (NOT_YET_RECRUITING)
- Centre Cardiologique du Nord — Saint-Denis, France (NOT_YET_RECRUITING)
- Clinique Rhéna — Strasbourg, France (NOT_YET_RECRUITING)
- Clinique Pasteur — Toulouse, France (NOT_YET_RECRUITING)
- CHRU Nancy, Institut Lorrain du coeur et des vaisseaux — Vandœuvre-lès-Nancy, France (NOT_YET_RECRUITING)
- Klinikum Coburg — Coburg, Germany (NOT_YET_RECRUITING)
- German Heart Center — Munich, Germany (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Isabel DEISENHOFER, MD — Deutsches Herzzentrum Muenchen
- Study coordinator: Paola MILPIED
- Email: paola.milpied@volta-medical.com
- Phone: (0)768025499
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.
Conditions: Atrial Fibrillation, Artificial Intelligence, VX1, Volta AF-Xplorer, Medical Device, Cardiac Dispersion, Volta Medical, Software