left ventricular dyssynchrony pacing induced cardiomyopathy
Conditions
Interventions
LVSP vs. RVP.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Age >=18 years with a life expectancy with good functional status of at least 1 year. - Class I or class IIa permanent pacing indication owing to an AV conduction disorder with an expected ventricular pacing percentage of >= 20%. AV conduction disorders include: - acquired third- or second-degree AV block. - atrial arrhythmia with slow ventricular conduction. - LVEF >= 40%. - Signed and dated informed consent form prior to admission to the trial.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Heart failure NYHA class III-IV - Class I indication for cardiac resynchronization therapy - Class I indication for implantable cardioverter defibrillator - Previous receipt of a cardiac implantable electronic device (except for implantable loop recorders) - Atrial arrhythmia with planned AV junction ablation - Unstable angina or acute myocardial infarction - Percutaneous or surgical coronary intervention within 30 days before enrollment - Valvular disease with an indication for valve repair or replacement - Hypertrophic cardiomyopathy with septal wall diameter > 2 cm - Renal insufficiency requiring hemodialysis - Active infectious disease or malignancy - Women who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to a LVEF below 50%, which as a binary combined endpoint will be determined at one year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Time to first occurrence of all cause mortality or hospitalization for heart failure. - Time to first occurrence of all cause mortality. - Time to first occurrence of hospitalization for heart failure. - Time to first occurrence of atrial fibrillation (AF) de novo. - The echocardiographic changes in LVEF at one year. - The echocardiographic changes in diastolic (dys-)function at one year. - The occurrence of pacemaker related complications. - Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA). The secondary endpoints (other than echocardiographic LVEF change) will be determined at the end of the follow-up period, when the last included patient has reached one year follow-up. The individual follow-up time for patients at this time point will vary with a minimum of one year. | — |
Countries
Netherlands
Outcome results
None listed