Last updated: October 26, 2023
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Heart Attack (Myocardial Infarction)
Congestive Heart Failure
Fast Heart Rate (Tachycardia)
Treatment
Endo-epicardial ablation
endocardial ablation only
Clinical Study ID
NCT05888662
35RC20_9765_EPIC-VT
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients over 18 years of age
- 1st radiofrequency ablation of VT complicating ischaemic heart disease
- Patients with an ICD and remote monitoring
- Having, for women of childbearing age, effective contraception until discharge fromhospital
- Have given their free and informed consent in writing
- are affiliated to or have health insurance
Exclusion
Exclusion Criteria:
- History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardialadhesions)
- Anticoagulant therapy that cannot be temporarily discontinued
- Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelettherapy
- History of pericarditis
- Previous thoracic radiotherapy
- Contraindication to general anaesthesia
- Pregnant or breastfeeding woman
- History of heparin-induced thrombocytopenia type 2 (as injection is required duringthe procedure)
- Person under legal protection (safeguard of justice, curatorship, guardianship),deprived of liberty, or unable to express consent
Study Design
Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Endo-epicardial ablation
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
October 23, 2028
Connect with a study center
CHU de Bordeaux
Bordeaux,
FranceSite Not Available
Centre Hospitalier Universitaire de Caen
Caen,
FranceSite Not Available
Centre Hospitalier de Clermont-Ferrand
Clermont-Ferrand,
FranceActive - Recruiting
Centre Hospitalier Régional Universitaire de Lille
Lille,
FranceSite Not Available
Hospices Civils de Lyon
Lyon,
FranceSite Not Available
CHU de Nantes
Nantes,
FranceActive - Recruiting
Hôpital Universitaire La Pitié-Salpêtrière - Paris
Paris,
FranceSite Not Available
CHU de Rennes
Rennes, 35033
FranceActive - Recruiting
Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
Toulouse,
FranceSite Not Available
Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
Tours,
FranceSite Not Available
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