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Randomized controlled trial to compare temporary permanent pacemaker versus temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement

Randomized controlled trial to compare temporary permanent pacemaker versus temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087536
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve disease

Interventions

Temporary permanent pacemaker group:Patients received temporary permanent pacemaker as a 1-month bridge after TAVR
Temporary pacemaker group:Maintain temporary pacemaker for 24-48 hours

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Patients who developed a new block during or 1 month after the TAVR operation (lasting more than 30 minutes or during the operation lasting until the end of the TAVR operation) met any of the following criteria and signed an informed consent to participate in the follow-up: 1. Third degree AVB occurred during TAVR procedure or within 1 month after TAVR; 2. Second degree type II AVB occurred during TAVR procedure or within 1 month after TAVR; 3. Second degree type I AVB occurred during TAVR procedure or within 1 month after TAVR; 4. First degree AVB (PR interval>300ms) occurred during TAVR procedure or within 1 month after TAVR with symptoms (Fatigue, dizziness, etc.); 5. Alternating bundle branch block occurred during TAVR procedure or within 1 month after TAVR; 6. Bifascicular block with syncope/blackness related symptoms occurred during TAVR procedure or within 1 month after TAVR.

Exclusion criteria

Exclusion criteria: 1. Permanent pacemaker was implanted before TAVR; 2. TAVR has indications of permanent pacemaker implantation before operation; 3. Conduction block caused by other diseases (such as neuromuscular disorders); 4. Patients had poor compliance and could not complete the study as required.

Design outcomes

Primary

MeasureTime frame
Rate PPM implantation at 6 month after TAVR;

Secondary

MeasureTime frame
Rate of PPM implantation at 1 month after TAVR;

Countries

China

Contacts

Public ContactGuangyuan Song

Beijing Anzhen Hospital, Capital Medical University

songgy_anzhen@vip.163.com+86 138 0112 0805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026