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

March 2, 2016 updated by: David Hildick-Smith, Royal Sussex County Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients post TAVI

Description

Inclusion Criteria:

  • All patients post TAVI

Exclusion Criteria:

  • Nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30 day mortality
Time Frame: 30 dyas
30 dyas

Secondary Outcome Measures

Outcome Measure
Time Frame
60 day mortality
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Sussex County Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (ESTIMATE)

March 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • TAVIPPMEarlyMortality

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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