Not Yet RecruitingNot Applicable

Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status

China112 participantsStarted 2024-09-15

Plain-language summary

This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".
✓. Age ≥18 years.
✓. Expected lifespan ≥1 year.
✓. Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups

Exclusion criteria

✕. Patients anticipated to have a high ventricular pacing proportion (\>40%) and with left ventricular ejection fraction less than 50%.
✕. Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
✕. Post-tricuspid valve mechanical valve replacement surgery.
✕. Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
✕. Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.

What they're measuring

Complete the survey questionnair before implanting a pacemaker

Timeframe: 1 day before implanting a pacemaker

The percentage of atrioventricular synchrony at 3 months after Micra AV implantation.

Timeframe: 3 months post-implant

Trial details

NCT IDNCT06587672

SponsorXiaohan Fan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-31

Contact for this trial

Xiaohan Fan

+861088322393 fanxiaohan@fuwaihospital.org

View on ClinicalTrials.gov More Pacemaker trials