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NCT02700633 Clinical Trial

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

TAVI Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02700633
Other study ID # TAVIPPMEarlyMortality
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 2, 2016
Last updated March 2, 2016
Start date February 2016

Study information
Verified date March 2016
Source Royal Sussex County Hospital
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4000
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients post TAVI

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Device:
• Pacemaker

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Royal Sussex County Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 30 day mortality 30 dyas No
Secondary 60 day mortality 60 days No
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Recruiting NCT06189976 - Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation N/A
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