Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiaohan Fan
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Micra AV implantation
Treatment groups
112 Participants
are divided into 1 treatment groupSponsors and collaborators
Xiaohan Fan
Lead sponsor
Fu Wai Hospital, Beijing, China
Sponsor institution
Tianjin Chest Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Beijing Hospital
Collaborator
Peking University First Hospital
Collaborator
Source ClinicalTrials.gov