Cardiac resynchronization therapy for adults with congenital heart disease and systemic right ventricle
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial
This study is testing if a special heart treatment can help adults with congenital heart disease and a systemic right ventricle feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 13 sites (Caen and 12 other locations) |
| Trial ID | NCT05524324 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of cardiac resynchronization therapy (CRT) in improving functional capacity and quality of life for adult patients with congenital heart disease who have a systemic right ventricle. It is a double-blind randomized cross-over trial involving 40 participants, each of whom will undergo both CRT ON (biventricular pacing) and CRT OFF (inactive or univentricular pacing) interventions over a follow-up period of 6 months. The study aims to provide evidence on whether CRT can be a viable treatment option for this specific patient population, potentially avoiding unnecessary procedures if found ineffective.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with systemic right ventricle and specific indications for CRT.
Not a fit: Patients who are pregnant, breastfeeding, or have had recent cardiac surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance the quality of life and functional capacity for patients with systemic right ventricle.
How similar studies have performed: While this approach is novel for this specific patient group, similar studies in other populations have shown promising results with CRT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * systemic right ventricle (SRV), * CRT-P or CRT-D device implanted for at least 1 month, * Age ≥18 years old, * One of the two following CRT indications: * NYHA II-IV, right ventricular ejection fraction ≤ 35% and spontaneous QRS duration ≥ 150 ms Or * NYHAI-IV, atrioventricular conduction disorders with ventricular pacing \> 40% (regardless right ventricular ejection fraction). * Affiliation to a french social security system (beneficiary or legal) * Informed and signed consent Exclusion Criteria: * Pregnancy or breastfeeding * Women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * Patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization), * Cardiac surgery during the last 3 months or planned during the next 6 months, * Percutaneous structural cardiac intervention planned during the next 6 months, * Persistent atrial arrhythmia with catheter ablation planned during the next 6 months, * Acute congestive heart failure, * Dysfunction of at least one CRT device lead that compromise biventricular pacing, * Patient on AME * Current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.
Where this trial is running
Caen and 12 other locations
- CHU de Caen — Caen, France (Recruiting)
- Hôpital Marie-Lannelongue — Le Plessis-Robinson, France (Recruiting)
- CHU de Lille — Lille, France (Not_yet_recruiting)
- Hôpital Louis Pradel — Lyon, France (Recruiting)
- Hôpital La Timone — Marseille, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- Ap-Hp Hegp — Paris, France (Recruiting)
- AP-HP, Pitié-Salpétrière — Paris, France (Recruiting)
- CHU de Rouen — Rouen, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
- Clinique Pasteur — Toulouse, France (Not_yet_recruiting)
- CHU de Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Victor WADLMANN — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Karine Goude
- Email: karine.goude@aphp.fr
- Phone: +33 1 44 84 17 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.