CompletedNot Applicable

Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Spain75 participantsStarted 2019-09-30

Plain-language summary

The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block). After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP. All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age of 18 years or more
✓. Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
✓. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>50%).
✓. Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.

Exclusion criteria

✕. Indication for implantable cardioverter defibrillator device.
✕. Patients with previous LVD and a recovered LVEF
✕. History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization
✕. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.

What they're measuring

Delta-LVEF at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT06026683

SponsorParc de Salut Mar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-02

View on ClinicalTrials.gov More Atrioventricular Block, Second and Third Degree trials