Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (… (NCT04730921) | Clinical Trial Compass
CompletedNot Applicable
Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)
China486 participantsStarted 2020-11-13
Plain-language summary
This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* a. Adult patients aged 18-90;
* b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)\> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP\>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;
* c. The subject is able to receive a pectoral implant;
* d. The subject is willing and able to comply with the protocol;
* e. The subject is expected to remain available for follow-up visits at the study centers.
* f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent
Exclusion Criteria:
* a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF\<50%);
* b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
* c. Patients with persistent atrial fibrillation;
* d. Pacemaker replacement without new implanted ventricular electrodes;
* e. Patients with implantable cardioverter-defibrillator (ICD) indications;
* f. Surgery is required within 1 year due to severe structural heart disease;
* g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery…
What they're measuring
1
The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.
Timeframe: Within two years after device implantation