NCT06825104 Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation
| NCT ID | NCT06825104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Volta Medical |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 278 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 278 participants in total. It began in 2025-03-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.
Eligibility 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Inclusion Criteria: * Patient who participated in the Tailored AF study * Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study * Patient able and willing to provide written informed consent to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
Contact & Investigator
Isabel DEISENHOFER, MD
PRINCIPAL INVESTIGATOR
Deutsches Herzzentrum Muenchen
Frequently Asked Questions
Who can join the NCT06825104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06825104 currently recruiting?
Yes, NCT06825104 is actively recruiting participants. Contact the research team at paola.milpied@volta-medical.com for enrollment information.
Where is the NCT06825104 trial being conducted?
This trial is being conducted at Bron, France, Clermont-Ferrand, France, Lomme, France, Marseille, France and 9 additional locations.
Who is sponsoring the NCT06825104 clinical trial?
NCT06825104 is sponsored by Volta Medical. The principal investigator is Isabel DEISENHOFER, MD at Deutsches Herzzentrum Muenchen. The trial plans to enroll 278 participants.
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