TAVI Clinical Trial
Official title:
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
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 |
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
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: |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Royal Sussex County Hospital |
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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