Assessing the implications of prophylactic permanent pacemaker implantation for patients undergoing Transcatheter Aortic Valve Implantation (TAVI)

Not Applicable

Completed

• Conditions: Heart Rhythm Disorder; Cardiac Valve Disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620001175965
• Lead Sponsor: A/Prof Dennis Lau

Brief Summary

We have identified specific characteristics associated with greater use of ventricular pacing after transcatheter aortic valve implant for patients receiving prophylactic permanent pacemaker.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Study Completion: 2022-10-07
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Transcatheter Aortic Valve Implantation (TAVI) performed at Royal Adelaide Hospital.
2) Permanent Pacemaker (PPM) implanted within 100 days pre-TAVI or 30 days post-TAVI.

Exclusion Criteria

.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of implantation of Transcatheter Aortic Valve Implant (TAVI) on pacing burden requirement assessed by the percentage of ventricular pacing during follow up.[Assessed from hospital medical records from implant until 31st December 2019, for prophylactic implant (up to 100 days pre-TAVI) and post-TAVI (up to 30 days post-TAVI) performed at Royal Adelaide Hospital between 1st January 2014 to 31st December 2019]

Secondary Outcome Measures

Name	Time	Method
Impact of implantation of Transcatheter Aortic Valve Implant (TAVI) on the rhythm status of patients with a Permanent Pacemaker (PPM) insitu assessed by the rhythm check performed during follow ups.[Assessed from hospital medical records from implant until 31st December 2019, for prophylactic implant (up to 100 days pre-TAVI) and post-TAVI (up to 30 days Post-TAVI) performed at Royal Adelaide Hospital between 1st January 2014 to 31st December 2019.];Any difference in pacing requirements between patients with PPM implanted post-TAVI and patients with PPM implanted pre-TAVI assessed by the programming mode selection and adjustment made for the PPM during follow up.[Assessed from hospital medical records from implant until 31st December 2019, for prophylactic implant (up to 100 days pre-TAVI) and post-TAVI (up to 30 days post-TAVI) performed at Royal Adelaide Hospital between 1st January 2014 to 31st December 2019.]