Actively Recruiting
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-07-11
40
Participants Needed
13
Research Sites
182 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
CONDITIONS
Official Title
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemic right ventricle (SRV)
- CRT-P or CRT-D device implanted for at least 1 month
- Age 18 years or older
- One of the two following CRT indications:
- NYHA class II-IV, right ventricular ejection fraction 35% or less, and spontaneous QRS duration 150 ms or more
- NYHA class I-IV, atrioventricular conduction disorders with ventricular pacing over 40%, regardless of right ventricular ejection fraction
- Affiliation to a French social security system (beneficiary or legal)
- Informed and signed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Women of childbearing potential without negative pregnancy test and without use of hormonal contraception, intrauterine device, or bilateral tubal occlusion
- Patient under legal protection measures (guardianship, curatorship, judicial safeguard, activated future protection mandate, family authorization)
- Cardiac surgery in the last 3 months or planned in the next 6 months
- Percutaneous structural cardiac intervention planned in the next 6 months
- Persistent atrial arrhythmia with catheter ablation planned in the next 6 months
- Acute congestive heart failure
- Dysfunction of at least one CRT device lead affecting biventricular pacing
- Patient receiving AME
- Current participation in another interventional clinical study or in an exclusion period after a previous study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
CHU de Caen
Caen, France
Actively Recruiting
2
Hôpital Marie-Lannelongue
Le Plessis-Robinson, France
Actively Recruiting
3
CHU de Lille
Lille, France
Not Yet Recruiting
4
Hôpital Louis Pradel
Lyon, France
Actively Recruiting
5
Hôpital La Timone
Marseille, France
Actively Recruiting
6
CHU de Montpellier
Montpellier, France
Actively Recruiting
7
CHU de Nantes
Nantes, France
Actively Recruiting
8
Ap-Hp Hegp
Paris, France, 75015
Actively Recruiting
9
AP-HP, Pitié-Salpétrière
Paris, France
Actively Recruiting
10
CHU de Rouen
Rouen, France
Actively Recruiting
11
CHU de Toulouse
Toulouse, France
Not Yet Recruiting
12
Clinique Pasteur
Toulouse, France
Not Yet Recruiting
13
CHU de Tours
Tours, France
Actively Recruiting
Research Team
K
Karine Goude
CONTACT
L
Laura Le Mao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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