Actively Recruiting
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-07-11
40
Participants Needed
13
Research Sites
12 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
Researchers are evaluating the impact of Cardiac Resynchronization Therapy (CRT) on functional capacity in adults with congenital heart disease and a systemic right ventricle (SRV). The study aims to provide the first evidence on CRT's effectiveness in patients with heart failure and SRV. This is a double-blind randomized cross-over trial involving 40 patients, with a follow-up period of 6 months. Participants who have heart failure with SRV and an implanted CRT device will be randomized to receive either an active CRT device (CRT ON) or an inactive device (CRT OFF) for 3 months. After this period, participants will switch to the other intervention for another 3 months. Two groups exist: one starts with CRT ON then switches to CRT OFF, and the other starts with CRT OFF then switches to CRT ON. During the study, participants will be monitored through various tests including the 6-minute walk test, peak oxygen uptake, and evaluation of heart function and symptoms. Quality of life, heart failure status, and device-related parameters will also be assessed. The study will track changes between the two 3-month treatment periods to determine the effects of CRT on functional capacity and other heart-related outcomes.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Have a systemic right ventricle (SRV)
- Have a CRT-P or CRT-D device implanted for at least 1 month
- Meet one of the following CRT indications:
- NYHA class II to IV, right ventricular ejection fraction 35% or less, and spontaneous QRS duration 150 ms or more
- NYHA class I to IV, atrioventricular conduction disorders with ventricular pacing more than 40%
- Affiliated with the French social security system as a beneficiary or legal representative
- Provided informed and signed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Women of childbearing potential without a negative pregnancy test and not using hormonal contraception, intrauterine device, or bilateral tubal occlusion
- Under legal protection measures such as guardianship or curatorship
- Cardiac surgery in the last 3 months or planned in the next 6 months
- Percutaneous structural cardiac intervention planned in the next 6 months
- Planned catheter ablation for persistent atrial arrhythmia in the next 6 months
- Acute congestive heart failure
- Dysfunction of at least one CRT device lead compromising biventricular pacing
- Patient receiving AME
- Current participation in another interventional clinical study or within exclusion period after a previous study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants have their cardiac resynchronization therapy (CRT) device activated or inactivated in a randomized order as part of a cross-over design.
Visits at the beginning and end of each 3-month period during the cross-over phases
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
L
Laura Le Mao
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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