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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
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT03058627 - Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation N/A
Recruiting NCT05235555 - EffecTAVI Registry
Not yet recruiting NCT05914051 - PRELOAD-TAVI Trial N/A
Active, not recruiting NCT03338582 - STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI N/A
Active, not recruiting NCT03424941 - The TransCatheter Valve and Vessels Trial N/A
Recruiting NCT06189976 - Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation N/A
Active, not recruiting NCT04298593 - Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study N/A
Completed NCT03966417 - Exercise Training After Transcatheter Aortic Valve Implantation N/A
Completed NCT04286893 - Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Recruiting NCT04831957 - Hypothyroidism After the TAVI Procedure in Elderly Patients N/A
Completed NCT01759563 - Oxygenation of the Cerebrum and Cooling During TAVI - Part I Phase 3
Not yet recruiting NCT05617196 - Virtual PREHAB Study for Patients Undergoing TAVI N/A
Not yet recruiting NCT04083040 - Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI) N/A
Recruiting NCT03283501 - Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL) N/A