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

Prophylactic permanent pacemaker implantation in Transcatheter Aortic Valve Implantation (TAVI) patients: Impact on heart rhythm and subsequent pacing burden requirement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001175965
Enrollment
30
Registered
2020-11-09
Start date
2020-11-30
Completion date
2022-10-07
Last updated
2022-10-16

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

Conditions

None listed

Brief summary

Transcatheter aortic valve implantation (TAVI) is a less-invasive, non-surgical approach for the treatment of severe aortic stenosis. With each successive generation of the transcatheter heart valve, combined with increasing experience of the proceduralists/heart teams, the outcomes have been more successful, and the risk of complications have been decreasing. One of the commonest complications of the TAVI procedure is the associated conduction abnormality (atrioventricular and intraventricular conduction blocks) which may require insertion of a Permanent Pacemaker (PPM). This is often performed post TAVI procedure, however certain patients undergo prophylactic insertion of PPM pre-TAVI. We will compare the follow up outcomes for each of these groups to assess differences in their heart rhythm following TAVI and associated requirement for PPM.

Interventions

Assess the change in pacing parameters of permanent pacemaker (PPM) associated with altered cardiac rhythm following TAVI performed at the Royal Adelaide Hospital between 1st January 2014 until 31st December 2019. This is a retrospective analysis of patients in the Structural Cardiology TAVI database. The intervention (TAVI) is the inclusion criteria for this database and the peri-procedural implant of a PPM is the inclusion criteria for this analysis. All data collected will be pooled for analy

Assess the change in pacing parameters of permanent pacemaker (PPM) associated with altered cardiac rhythm following TAVI performed at the Royal Adelaide Hospital between 1st January 2014 until 31st December 2019. This is a retrospective analysis of patients in the Structural Cardiology TAVI database. The intervention (TAVI) is the inclusion criteria for this database and the peri-procedural implant of a PPM is the inclusion criteria for this analysis. All data collected will be pooled for analysis to answer the hypotheses as listed. The pacing parameters over follow up of patients who had Pre-TAVI (prophylactic) PPM implantation will be compared against patients who had Post-TAVI PPM implantation.

Sponsors

A/Prof Dennis Lau
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Nil.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026