PacemakerTAVI PACERNCT06542380
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
An observational study of Pacemaker and TAVI, run by German Heart Institute at 1 site in Germany.
Trial summary
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Read more about this study
- Who is it for?
- Ages 51 to 95 years
- Conditions the study is for
- Pacemaker, TAVI, Risk Score
- What is being tested?
- TAVI, pacemaker
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 7 Feb 2022to 28 Jun 2024
- 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 51 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Given the retrospective nature of the study, all patients who had undergone TAVI at the DHZC were included, with the exception of those meeting the exclusion criteria mentioned above. Consequently, the study population is primarily comprised of individuals aged 75 years and above, with a balanced gender distribution. Following current guidelines, every patient undergoing TAVI received an initial assessment by a multidisciplinary heart team.
Who may be able to join
- Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020
Who cannot join
- previous device implantation
- valve-in-valve procedure
- patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)
Trial locations and contacts
1 site in 1 country.
About this study
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.
- Conditions
- Pacemaker, TAVI, Risk Score
- Being tested
- TAVI, pacemaker
- Keywords
- Transcatheter aortic valve replacement, Aortic stenosis, Pacemaker implantation, Risk Score, Electrocardiogram, Risk Stratification
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI, pacemakerDevice
Retrospective analysis of need for pacemaker implantation after TAVI
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing TAVI at DHZC 2019-2021 | Not described Receives: Device: TAVI, pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacemaker Implantation
Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines
Measured: 30 days after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start7 Feb 2022
- Primary completion30 Nov 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Lueg, German Heart Institute
- Investigators
- Henryk Dreger, Professor, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542380
- Sponsor's protocol ID
- DRKS00024852
- Acronym
- TAVI PACER
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
- ClinicalTrials.gov ID
- NCT06542380
- Acronym / sponsor ID
- TAVI PACER / DRKS00024852
- Conditions
- Pacemaker, TAVI, Risk Score
- Keywords
- Transcatheter aortic valve replacement, Aortic stenosis, Pacemaker implantation, Risk Score, Electrocardiogram, Risk Stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 7 Aug 2024 (actual)
- 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.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing TAVI at DHZC 2019-2021 | – | Device: TAVI, pacemaker |
Who may qualify
- Ages
- 51 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given the retrospective nature of the study, all patients who had undergone TAVI at the DHZC were included, with the exception of those meeting the exclusion criteria mentioned above. Consequently, the study population is primarily comprised of individuals aged 75 years and above, with a balanced gender distribution. Following current guidelines, every patient undergoing TAVI received an initial assessment by a multidisciplinary heart team.
Key inclusion criteria (1 listed)
- Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020
Key exclusion criteria (3 listed)
- previous device implantation
- valve-in-valve procedure
- patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)
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 |
|---|---|---|
| TAVI, pacemakerRetrospective analysis of need for pacemaker implantation after TAVI | Device | Patients undergoing TAVI at DHZC 2019-2021 |
Primary outcome
Pacemaker Implantation
Time frame: 30 days after TAVI
Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
Henryk Dreger, Professor principal investigator
German Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and TAVI, run by German Heart Institute at 1 site in Germany.
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 3 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: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pacemaker Implantation (time frame: 30 days after TAVI). 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 Aug 2024.