Permanent left ventricular septal pacing versus right ventricular pacing in patients with atrioventricular conduction disorders: a randomized trial: LEAP trial.

Recruiting

Conditions: left ventricular dyssynchrony
pacing induced cardiomyopathy
10007521

Registration Number: NL-OMON54534

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 400

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a composite of all-cause mortality, hospitalization for<br /><br>heart failure, and a more than 10% point decrease in left ventricular ejection<br /><br>fraction (LVEF) leading to a LVEF below 50%, which as a binary combined<br /><br>endpoint will be determined at one year follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>- Time to first occurrence of all cause mortality or hospitalization for heart<br /><br>failure.<br /><br>- Time to first occurrence of all cause mortality.<br /><br>- Time to first occurrence of hospitalization for heart failure.<br /><br>- Time to first occurrence of atrial fibrillation (AF) de novo.<br /><br>- The echocardiographic changes in LVEF at one year.<br /><br>- The echocardiographic changes in diastolic (dys-)function at one year.<br /><br>- The occurrence of pacemaker related complications.<br /><br>- Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact<br /><br>analysis (BIA).<br /><br>The secondary endpoints (other than echocardiographic LVEF change) will be<br /><br>determined at the end of the follow-up period, when the last included patient<br /><br>has reached one year follow-up. The individual follow-up time for patients at<br /><br>this time point will vary with a minimum of one year.</p><br>