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BOTAF - Prevention of post-operative Atrial Fibrillation by BOTulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513645-37-00
Acronym
P170912J
Enrollment
220
Registered
2024-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with indication for conventional cardiac surgery (CABG, aortic replacement, or ascending aorta surgery)

Brief summary

The incidence of rhythm disorders of postoperative AF in patients undergoing cardiac surgery at 3 weeks defined as atrial arrhythmia during at least 30 seconds continuously within 21 days after cardiac surgery. It will be measured through both holter ECG Spiderflash-t recorder during the first 21 days post-op and ECG daily monitoring during the first 7 days after surgery. Two blinded cardiologists will independently adjudicate the primary end point.

Interventions

DRUGpoudre pour solution injectable
DRUGPlacebo of Xeomin 200 U

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The incidence of rhythm disorders of postoperative AF in patients undergoing cardiac surgery at 3 weeks defined as atrial arrhythmia during at least 30 seconds continuously within 21 days after cardiac surgery. It will be measured through both holter ECG Spiderflash-t recorder during the first 21 days post-op and ECG daily monitoring during the first 7 days after surgery. Two blinded cardiologists will independently adjudicate the primary end point.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026