Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI

• Conditions: TAVI
• Interventions: Device: Pacemaker

• Registration Number: NCT02700633
• Lead Sponsor: Royal Sussex County Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Study First Posted: 2016-03-07
• Last Update Posted: 2016-03-07
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• All patients post TAVI

Exclusion Criteria

• Nil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Those with pacemaker at discharge	Pacemaker	Landmark analysis of early mortality dependant on pacemaker status at discharge

Primary Outcome Measures

Name	Time	Method
30 day mortality	30 dyas

Secondary Outcome Measures

Name	Time	Method
60 day mortality	60 days