Overview

This trial is active, not recruiting.

Condition tavi
Treatment pacemaker
Sponsor Royal Sussex County Hospital
Start date February 2016
End date July 2016
Trial size 4000 participants
Trial identifier NCT02700633, TAVIPPMEarlyMortality

Summary

Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Landmark analysis of early mortality dependant on pacemaker status at discharge
pacemaker
Landmark analysis of early mortality dependant on pacemaker status at discharge

Primary Outcomes

Measure
30 day mortality
time frame: 30 dyas

Secondary Outcomes

Measure
60 day mortality
time frame: 60 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients post TAVI Exclusion Criteria:

Additional Information

Official title Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Royal Sussex County Hospital.