Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle… (NCT05524324) | Clinical Trial Compass
RecruitingNot Applicable
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
France40 participantsStarted 2022-11-15
Plain-language summary
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
6-minute walk test
Timeframe: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)