ClinicalTrials.gg
Status unknownNCT02700633Updated Mar 7, 2016

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

An observational study in TAVI, sponsored by Royal Sussex County Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-07.

Sponsored by Royal Sussex County Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,000
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • TAVI
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In context

Lead sponsor

Royal Sussex County Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients post TAVI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients post TAVI

Exclusion criteria

Exclusion Criteria:

  • Nil
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePacemaker
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What researchers measure

Primary outcomes

  1. 30 day mortality

    Time frame: 30 dyas

Secondary outcomes

  1. 60 day mortality

    Time frame: 60 days

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02700633
Lead sponsor
Royal Sussex County Hospital
Responsible party
David Hildick-Smith (Consultant Cardiologist, Royal Sussex County Hospital) — Principal investigator
First posted
Mar 7, 2016
Start date
Feb 2016
Primary completion
Jul 2016 (estimated)
Last update
Mar 7, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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