Status:
NOT_YET_RECRUITING
Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
Lead Sponsor:
Xiaohan Fan
Collaborating Sponsors:
Tianjin Chest Hospital
Beijing Friendship Hospital
Conditions:
Pacemaker
Atrioventricular Block
Eligibility:
All Genders
18+ years
Brief 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 a...
Detailed Description
Traditional pacemakers consist of a pulse generator and leads. Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemaker...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06587672
Start Date
September 15 2024
End Date
July 31 2027
Last Update
September 19 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Fu Wai Hospital
Beijing, Beijing Municipality, China, 100037
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100037