NCT02700633

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 2, 2016

Last Update Submit

March 2, 2016

Conditions

TAVI

Outcome Measures

Primary Outcomes (1)

  • 30 day mortality

    30 dyas

Secondary Outcomes (1)

  • 60 day mortality

    60 days

Study Arms (2)

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

Interventions

PacemakerDEVICE
Those with pacemaker at discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients post TAVI

You may qualify if:

  • All patients post TAVI

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 7, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Last Updated

March 7, 2016

Record last verified: 2016-03