Overview
Sponsor-declared trial summary
Adult patients with indication for conventional cardiac surgery (CABG, aortic replacement, or ascending aorta surgery)
To determine the efficacy of Botulinum toxin injection into epicardial fat pads for the prevention of postoperative AF in patients undergoing cardiac surgery within three weeks following cardiac surgery
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 5 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- French Ministry of Health and Merz Pharma
External identifiers
- EU CT number
- 2024-513645-37-00
- EudraCT number
- 2018-002541-11
- ClinicalTrials.gov
- NCT04075981
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
To determine the efficacy of Botulinum toxin injection into epicardial fat pads for the prevention of postoperative AF in patients undergoing cardiac surgery within three weeks following cardiac surgery
Conditions and MedDRA coding
Adult patients with indication for conventional cardiac surgery (CABG, aortic replacement, or ascending aorta surgery)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10067824 | Prophylaxis against atrial fibrillation | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Indication for cardiac surgery (CABG, aortic valve repair or aortic valve replacement excluding the sutureless valve, ascending aorta surgery), according to the European Heart Association guidelines. - Patients in hemodynamically stable condition. - Sinus rhythm at moment of randomisation (ECG). - Age: ≥18 to ≤80 years old. - Negative serum or urinary β-hCG for women of child-bearing potential. - Patients able to attend several consultations at the centre. - Informed consent signed. - Affiliation to French social security regime.
Exclusion criteria 1
- - Previous cardiac surgery. - Persistent AF or atrial tachycardia. - Planned maze procedure or pulmonary vein (PV) isolation. - Use of class I or III antiarrhythmic drugs within 5 elimination half-life of the drug (for amiodarone: one year). - Mitral or tricuspid valve surgery. - Congenital cardiomyopathy. - Neuro-muscular disease including disorders of pre-operative swallowing - Protected populations e.g. minor patient, breastfeeding women, patients under legal guardianship, curatorship or legal protection. . - Participation in another interventional trial. - Unwillingness to participate. - Contraindications to botulinum toxin under investigation or to the excipients: known hypersensitivity. - Patient with active endocarditis. - Minimal invasive surgery (ministernotomy).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
XEOMIN 200 unités, poudre pour solution injectable
PRD4411682 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 200 U unit(s)
- Max total dose
- 200 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 34009 550 221 5 2
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Emmanuelle FLORENS
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Emmanuelle FLORENS
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 220 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-09-05 | 2024-09-30 | 2025-09-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513645-37-00 | 7-0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF adulte | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF adulte addendum | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Xeomin 200 U | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-513645-37-00 | 7-0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | France | Acceptable 2024-08-26
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-04 | France | Acceptable 2024-10-28
|
2024-11-19 |