Trials / Recruiting

RecruitingNCT05524324

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 40 (estimated)

Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.

Detailed description

This study will be the first to bring evidence on CRT efficacy in ACHD patients with heart failure and SRV. If results are positives, CRT may improve functional capacities and quality of life of patients and will become an option of choice in this population. If results are negatives, futile CRT implantation may be avoided in this population in particular considering potential adverse effects and CRT-related complications. Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.

Conditions

Interventions

Type	Name	Description
DEVICE	CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)	Patients randomized to the CRT ON / CRT OFF arm will undergo a first intervention to activate their device and then a second intervention for 3 months to inactivate their device.
DEVICE	CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)	Patients randomized to the CRT OFF / CRT ON arm will undergo a first intervention to inactivate their device and then a second intervention for 3 months to activate their device.

Timeline

Start date: 2022-11-15
Primary completion: 2026-02-15
Completion: 2026-05-15
First posted: 2022-09-01
Last updated: 2024-07-11

Locations

13 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05524324. Inclusion in this directory is not an endorsement.