Aortic Valve StenosisConductNCT03497611
Edwards SAPIEN 3 PPI Registry
An observational study of Aortic Valve Stenosis and AV Block, run by Institut für Pharmakologie und Präventive Medizin at 4 sites in Germany.
Trial summary
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets. Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- What is being tested?
- transcatheter valve implantation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 4 sitesGermany
- Study dates
- 30 Apr 2018to 3 Mar 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that already underwent transfemoral transcatheter valve implantation with the SAPIEN 3 valve
Who may be able to join
- Patients that already underwent Edwards SAPIEN 3 implantation because of aortic stenosis
Who cannot join
- Patients with prior pacemaker or intended valve in valve implantation
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Herzzentrum, Universität Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern
Münster, North Rhine-Westphalia, 48149
University Clinic Tübingen, Department of Internal Medicine III
Tübingen, Baden-Wurttemberg, 72076
University Clinic Ulm, Department of Internal Medicine II
Ulm, Baden-Wurttemberg, 89073
About this study
Official title: Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).
Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.
Read the detailed description
Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure.
While a number of registries have documented the rates of PPI with different valves, much less evidence has been provided for 1) patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for 2) procedural variables (e.g. implantation depth, valve size etc.) that should be considered to perform an as safe and minimal invasive procedure as possible.
Prior research To date there are 7 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV (see Table). These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% derived from patient numbers between 131 and 335. These analyses resulted in the identification of pre-existing conduction disturbance / aortic valve calcification as patient related and implantation depth /oversizing as procedure related variables associated with Edwards SAPIEN 3 THV TAVI. Furthermore a scoring algorithm for patient related factors has been proposed from a dataset of 240 patients to predict the likelihood of PPI after THV .
Limitations of prior research Current evidence though is limited by patient numbers versus event rates (with a max. of 62 PPI considered in any of the available datasets) resulting in a limited power in multivariable analyses, the single center design of these ventures, the lack of a consistent definition of variables potentially associated and the unexplained differences in the number and type of variables identified.
Aims For this reason the investigators consider it necessary to 1) to retrospectively pool data from all of these 7 datasets to arrive at a more comprehensive picture of patient related variables (retrospective part I), to 2) assess procedural variables in a prospective multicenter registry (prospective part II) and 3) to potentially validate the identified variables in a future prospective cohort.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Being tested
- transcatheter valve implantation
- Keywords
- Transcatheter aortic valve implantation, Pacemaker, Aortic valve calcification, PPI
- Medical subject headings
- Aortic Valve Stenosis, Atrioventricular Block, Bundle-Branch Block, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter valve implantationProcedure or surgery
aortic transcatheter valve implantation using Edwards SAPIEN 3 valve
| Study group | Role | What they receive |
|---|---|---|
| Patients with aortic stenosis | Patients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation Receives: Procedure: transcatheter valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of PPI after TAVI
need for permanent pacemaker implantation after TAVI
Measured: 30 days
Secondary outcomes (2)
Timing of PPI
Time interval after TAVI until PPI in days
Measured: 30 days
Indications for PPI
possible reasons to implant a PP:
- 1° AV block
- complete RBBB
- complete LBBB
- QRS duration prolonged
- LVOT calcium volume below the left and right cusp
- etc
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start30 Apr 2018
- Primary completion3 Nov 2018
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Tobias Geisler, Prof., Principal investigator, University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497611
- Sponsor's protocol ID
- Conduct
- Acronym
- Conduct
- Status last verified
- Sep 2020
- First submitted
- 26 Mar 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be made available
Publications
Droppa M, Rudolph TK, Baan J, Nielsen NE, Baumgartner H, Vendrik J, Froehlich M, Borst O, Wohrle J, Gawaz M, Potratz P, Hack LP, Mauri V, Baranowski J, Bramlage P, Kurucova J, Thoenes M, Rottbauer W, Geisler T. Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis. Heart Vessels. 2020 Dec;35(12):1735-1745. doi: 10.1007/s00380-020-01653-6. Epub 2020 Jun 26.
PubMed 32591894Rudolph T, Droppa M, Baan J, Nielsen NE, Baranowski J, Hachaturyan V, Kurucova J, Hack L, Bramlage P, Geisler T. Modifiable risk factors for permanent pacemaker after transcatheter aortic valve implantation: CONDUCT registry. Open Heart. 2023 Feb;10(1):e002191. doi: 10.1136/openhrt-2022-002191.
PubMed 36750275
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve
- ClinicalTrials.gov ID
- NCT03497611
- Acronym / sponsor ID
- Conduct / Conduct
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Keywords
- Transcatheter aortic valve implantation, Pacemaker, Aortic valve calcification, PPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 3 Nov 2018 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 13 Apr 2018 (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.
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).
Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.
Detailed description
Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure.
While a number of registries have documented the rates of PPI with different valves, much less evidence has been provided for 1) patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for 2) procedural variables (e.g. implantation depth, valve size etc.) that should be considered to perform an as safe and minimal invasive procedure as possible.
Prior research To date there are 7 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV (see Table). These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% derived from patient numbers between 131 and 335. These analyses resulted in the identification of pre-existing conduction disturbance / aortic valve calcification as patient related and implantation depth /oversizing as procedure related variables associated with Edwards SAPIEN 3 THV TAVI. Furthermore a scoring algorithm for patient related factors has been proposed from a dataset of 240 patients to predict the likelihood of PPI after THV .
Limitations of prior research Current evidence though is limited by patient numbers versus event rates (with a max. of 62 PPI considered in any of the available datasets) resulting in a limited power in multivariable analyses, the single center design of these ventures, the lack of a consistent definition of variables potentially associated and the unexplained differences in the number and type of variables identified.
Aims For this reason the investigators consider it necessary to 1) to retrospectively pool data from all of these 7 datasets to arrive at a more comprehensive picture of patient related variables (retrospective part I), to 2) assess procedural variables in a prospective multicenter registry (prospective part II) and 3) to potentially validate the identified variables in a future prospective cohort.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aortic stenosis | – | Procedure: transcatheter valve implantationPatients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that already underwent transfemoral transcatheter valve implantation with the SAPIEN 3 valve
Key inclusion criteria (1 listed)
- Patients that already underwent Edwards SAPIEN 3 implantation because of aortic stenosis
Key exclusion criteria (1 listed)
- Patients with prior pacemaker or intended valve in valve implantation
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 |
|---|---|---|
| transcatheter valve implantationaortic transcatheter valve implantation using Edwards SAPIEN 3 valve | Procedure or surgery | Patients with aortic stenosis |
Primary outcome
occurence of PPI after TAVI
Time frame: 30 days
need for permanent pacemaker implantation after TAVI
2 secondary outcomes
Timing of PPI
Time frame: 30 days
Indications for PPI
Time frame: 30 days
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 4 Sep 2020.
- Results publication: PubMed 32591894Droppa M, Rudolph TK, Baan J, Nielsen NE, Baumgartner H, Vendrik J, Froehlich M, Borst O, Wohrle J, Gawaz M, Potratz P, Hack LP, Mauri V, Baranowski J, Bramlage P, Kurucova J, Thoenes M, Rottbauer W, Geisler T. Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis. Heart Vessels. 2020 Dec;35(12):1735-1745. doi: 10.1007/s00380-020-01653-6. Epub 2020 Jun 26.
- Derived from this study: PubMed 36750275Rudolph T, Droppa M, Baan J, Nielsen NE, Baranowski J, Hachaturyan V, Kurucova J, Hack L, Bramlage P, Geisler T. Modifiable risk factors for permanent pacemaker after transcatheter aortic valve implantation: CONDUCT registry. Open Heart. 2023 Feb;10(1):e002191. doi: 10.1136/openhrt-2022-002191.
- Individual participant dataSharing planned: No. no IPD will be made available
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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.
Tobias Geisler, Prof. principal investigator
University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and AV Block, run by Institut für Pharmakologie und Präventive Medizin at 4 sites 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 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: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
occurence of PPI after TAVI (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497611, which also lists 2 linked publications.
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 4 Sep 2020.