Cardiac Resynchronization Therapy in Congenital Heart Defects (CARE-CHD)

Competence Network for Congenital Heart Defects

Status and phase

Completed

Phase 3

Phase 2

Conditions

Congenital Heart Defects

Treatments

Device: Implantation and testing of CRT

Study type

Interventional

Funder types

Other

Identifiers

NCT00450684

CARE-CHD

Details and patient eligibility

About

The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design).

The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max).

55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).

Enrollment

55 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with congenital heart defects
Heart failure of the Morphologically right or left system ventricle with an absolute ejection fraction of < 40% in the failed ventricle
NYHA classes II-IV
Optimal drug therapy for heart failure according to the ESC guidelines
QRS interval ≥ 120 ms (demonstrated in at least two relevant ECG derivations, depending on existing bundle branch block symptoms)
Patients with chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above-mentioned criteria
Patients with morphologically right ventricle in system position and significant insufficiency of the systemic atrioventricular valve, if they also meet the criteria listed above

Exclusion criteria

PTCA, cardiomyoplasty or myocardial infarction / unstable angina pectoris or cerebral insult within the 6 weeks preceding the planned cardiac resynchronisation therapy
Patients with pulmonary hypertension / Eisenmenger's syndrome
Life expectancy < 1 year due to a non-cardiac disease
Anticipated poor compliance by the patient
Pregnancy and breastfeeding
Known or persistent abuse of prescription medicines, recreational drugs or alcohol