Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Sponsor
Royal Sussex County Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02700633
Collaborator
(none)
4,000
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
4000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Study Start Date
:
Feb 1, 2016
Anticipated Primary Completion Date
:
Jul 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Those with pacemaker at discharge Landmark analysis of early mortality dependant on pacemaker status at discharge |
Device: Pacemaker
|
| Those without pacemaker at discharge Landmark analysis of early mortality dependant on pacemaker status at discharge |
Outcome Measures
Primary Outcome Measures
- 30 day mortality [30 dyas]
Secondary Outcome Measures
- 60 day mortality [60 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All patients post TAVI
Exclusion Criteria:
- Nil
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Royal Sussex County Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
David Hildick-Smith,
Consultant Cardiologist,
Royal Sussex County Hospital
ClinicalTrials.gov Identifier:
NCT02700633
Other Study ID Numbers:
- TAVIPPMEarlyMortality
First Posted:
Mar 7, 2016
Last Update Posted:
Mar 7, 2016
Last Verified:
Mar 1, 2016