TAVINCT02700633
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
An observational study of TAVI, run by Royal Sussex County Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TAVI
- What is being tested?
- Pacemaker
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients post TAVI
Who may be able to join
- All patients post TAVI
Who cannot join
- Nil
About this study
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
- Conditions
- TAVI
- Being tested
- Pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacemakerDevice
| Study group | Role | What they receive |
|---|---|---|
| Those with pacemaker at discharge | Landmark analysis of early mortality dependant on pacemaker status at discharge Receives: Device: Pacemaker | |
| Those without pacemaker at discharge | Landmark analysis of early mortality dependant on pacemaker status at discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
Measured: 30 dyas
Secondary outcomes (1)
60 day mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Sussex County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hildick-Smith, Royal Sussex County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700633
- Sponsor's protocol ID
- TAVIPPMEarlyMortality
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
- ClinicalTrials.gov ID
- NCT02700633
- Acronym / sponsor ID
- TAVIPPMEarlyMortality
- Conditions
- TAVI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Royal Sussex County HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (estimated)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Those with pacemaker at discharge | – | Device: PacemakerLandmark analysis of early mortality dependant on pacemaker status at discharge |
| Those without pacemaker at discharge | – | –Landmark analysis of early mortality dependant on pacemaker status at discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients post TAVI
Key inclusion criteria (1 listed)
- All patients post TAVI
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker | Device | Those with pacemaker at discharge |
Primary outcome
30 day mortality
Time frame: 30 dyas
1 secondary outcome
60 day mortality
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of TAVI, run by Royal Sussex County Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality (time frame: 30 dyas). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.