RecruitingNot ApplicableNCT05524324

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

40 participants

Start Date

Nov 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the effectiveness of cardiac resynchronization therapy (CRT) — a type of specialized pacemaker — in patients with a congenital heart condition called systemic right ventricle, where the heart's right side does the work normally done by the left side, causing it to gradually weaken. **You may be eligible if...** - You are 18 years or older - You have a systemic right ventricle (a congenital heart condition) - You have already had a CRT device (pacemaker) implanted for at least 1 month - You have moderate to severe heart failure symptoms (NYHA class II–IV) with a weak right ventricle AND prolonged electrical delay, OR you have significant heart block with a high pacing burden - You are enrolled in the French social security system **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are a woman of childbearing age without effective contraception - You have had heart surgery in the past 3 months or have major cardiac procedures planned in the next 6 months - You have uncontrolled persistent heart rhythm problems (atrial arrhythmia with planned ablation) - You are currently in acute heart failure - You are currently participating in another interventional clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECRT 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.

DEVICECRT 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.


Locations(13)

CHU de Caen

Caen, France

Hôpital Marie-Lannelongue

Le Plessis-Robinson, France

CHU de Lille

Lille, France

Hôpital Louis Pradel

Lyon, France

Hôpital La Timone

Marseille, France

CHU de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

Ap-Hp Hegp

Paris, France

AP-HP, Pitié-Salpétrière

Paris, France

CHU de Rouen

Rouen, France

CHU de Toulouse

Toulouse, France

Clinique Pasteur

Toulouse, France

CHU de Tours

Tours, France

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NCT05524324


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