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

NCT ID: NCT02700633

Last Updated: 2016-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Brief Summary

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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

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Conditions

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TAVI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Those with pacemaker at discharge

Landmark analysis of early mortality dependant on pacemaker status at discharge

Pacemaker

Intervention Type DEVICE

Those without pacemaker at discharge

Landmark analysis of early mortality dependant on pacemaker status at discharge

No interventions assigned to this group

Interventions

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Pacemaker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients post TAVI

Exclusion Criteria

* Nil
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Sussex County Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Hildick-Smith

Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TAVIPPMEarlyMortality

Identifier Type: -

Identifier Source: org_study_id

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