Aortic Valve StenosisConduct-proNCT03715894
Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry
An observational study of Aortic Valve Stenosis and AV Block, run by Institut für Pharmakologie und Präventive Medizin at 5 sites in 3 countries.
Trial summary
There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. 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
- 300 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Dec 2018to 30 Mar 2023
- 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 undergoing transfemoral transcatheter valve implantation with the SAPIEN 3 valve with at least one identified risk factor for PPI
Who may be able to join
- Patients undergoing transfemoral SAPIEN 3 implantation because of aortic stenosis,
- at least 1 of the identified risk factors from the retrospective part to ensure a minimum risk of 33% for PPI (presumed: pre-existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, QRS duration or short membranous septum,to be confirmed);
Who cannot join
- with indications for pacemaker implantation prior to TAVI
- valve in valve implantation or
- without informed consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Herz- und Diabeteszentrum
Bad Oeynhausen, North Rhine-Westphalia, 32545
University Clinic Tübingen, Department of Internal Medicine III
Tübingen, Baden-Wurttemberg, 72076
University Clinic Ulm, Department of Internal Medicine II
Ulm, Baden-Wurttemberg, 89073
Sweden1 site
Dept of Cardiology, Linköping University Hospital,
Linköping, 58183
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 procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI
Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. Additional assessment of calcification using a CT data core lab. Statistical analysis of the dataset obtained 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
- patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for
- procedural variables (e.g. implantation hieght, valve size etc.) that should be considered to perform as safe and minimal invasive procedure as possible.
Prior Research To date there are 8 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV.
These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% based on patient numbers between 131 and 335 patients.
These analyses resulted in the identification of pre-existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, prolonged QRS duration or short membranous septum as patient related factors associated with PPI during Edwards SAPIEN 3 THV TAVI. Similarly, procedural variables such as implantation height /oversizing as procedure related variables are associated with PPI after TAVI.
The literature regarding procedure related variables associated with permanent pacemaker implantation in patients receiving an Edwards SAPIEN 3 valve shows multivariable analyses with slightly different views to the requested procedural variables.
Tarantini et al. suggest a higher valve implantation (ventricular ratio >60/40 at qualitative assessment or depth <8mm at qualitative assessment). A similar outcome was reported by De Torres-Alba et al.. Due to the longer stent of the SAPIEN 3 they suggest an even higher implantation, intending a shorter extension of the stent into the LVOT by increasing the percentage of the stent in the aorta to >70%. Schwerg et al. compare the PPI rate in "low implantation" with "high implantation" independently from the patients pre-existing conduction disturbances, and suggest to minimize the risk of PPI by choosing a higher implantation technique with the central marker 2 mm or more over the annular plane.
Furthermore Mauri et al. encourage to choose a implantation height of <25.5% (Implantation height was expressed as the percentage of the ventricular part of the stent frame in relation to the overall stent frame length).
Another procedural factor is found to be aortic annulus oversizing ratios which are known to prevent paravalvular leakage. Leber et al. show the rate of post-procedural permanent pacemakers tended to be lower in patients with <15% oversizing compared to those with >25% oversizing for Edwards Sapien XT. Using SAPIEN 3 valves Husser et al. show a higher PPI rate in patients with out of range oversizing.
Gonska et al. conclude that neither implantation height nor oversizing has an effect on PPI rate.
On the other hand the need for pre-dilatation by balloon valvuloplasty and post-implant dilatation have not been identified as potential contributing factors for PPI as it is believed the impact of the dilatation on the conduction tissue is transient and short lived.
Nevertheless, pre- and post-dilatation should be further considered and analysed.
Hypothetically, also the following procedural parameters, which have not been investigated in detail so far, could be risks for PPIs: Stiff guidewire use or a no touch policy and should be considered in this research.
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 with PPI and the unexplained differences in the number and type of variables identified.
Aims This registry aims to assess procedural variables and to verify risk factors in a prospective multicenter registry.
To identify predictors of PPI patients with a high risk for PPI will be preferably included to increase the power compared to pre-existing database analyses from single centres. The target is to identify general procedural predictors and to verify risk factors of PPI post TAVI with the Edwards SAPIEN 3 valve which when identified and avoided will reduce the need of PPI in the future.
- 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 aortic transcatheter valve Implantation, who are with a high risk for PPI Receives: Procedure: transcatheter valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of permanent pacemaker implantation after TAVI in high risk patients
Need for permanent pacemaker implantation after TAVI in high risk patients.
Measured: 1 year
Secondary outcomes (4)
Implantation depth
Measurement in peri-interventional aortic angiograms. Mean implantation depth (% ventricular part of the stent frame)
Measured: up to 30 days after intervention
Valve sizing
Measurement of aorta in pre-operative contrast multislice computed tomographic Images, compared to the implanted valve sizing. Percentage of oversizing will be calculated using the formula (nominal prosthesis area/multislice computed tomographic area - 1) x 100
Measured: up to 30 days after intervention
Dilatation
Ratio in patients, who get a dilatation before or at intervention as well as thereafter (discharge, FU)
Measured: 1 year
Expiration data
cause of death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Dec 2018
- Primary completion15 Oct 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Prospective
- Enrolment
- 300 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
- NCT03715894
- Sponsor's protocol ID
- Conduct prospective
- Acronym
- Conduct-pro
- Status last verified
- Jun 2023
- First submitted
- 2 Oct 2018
- Last updated
- 15 Jun 2023
- 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
Bob-Manuel T, Nanda A, Latham S, Pour-Ghaz I, Skelton WP 4th, Khouzam RN. Permanent pacemaker insertion in patients with conduction abnormalities post transcatheter aortic valve replacement: a review and proposed guidelines. Ann Transl Med. 2018 Jan;6(1):11. doi: 10.21037/atm.2017.10.21.
PubMed 29404357De Torres-Alba F, Kaleschke G, Diller GP, Vormbrock J, Orwat S, Radke R, Reinke F, Fischer D, Reinecke H, Baumgartner H. Changes in the Pacemaker Rate After Transition From Edwards SAPIEN XT to SAPIEN 3 Transcatheter Aortic Valve Implantation: The Critical Role of Valve Implantation Height. JACC Cardiovasc Interv. 2016 Apr 25;9(8):805-813. doi: 10.1016/j.jcin.2015.12.023. Epub 2016 Mar 23.
PubMed 27017367Maeno Y, Abramowitz Y, Kawamori H, Kazuno Y, Kubo S, Takahashi N, Mangat G, Okuyama K, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.
PubMed 28412434Tarantini G, Mojoli M, Purita P, Napodano M, D'Onofrio A, Frigo A, Covolo E, Facchin M, Isabella G, Gerosa G, Iliceto S. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015 Jul;11(3):343-50. doi: 10.4244/EIJY14M11_06.
PubMed 25405801Mauri V, Reimann A, Stern D, Scherner M, Kuhn E, Rudolph V, Rosenkranz S, Eghbalzadeh K, Friedrichs K, Wahlers T, Baldus S, Madershahian N, Rudolph TK. Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2200-2209. doi: 10.1016/j.jcin.2016.08.034.
PubMed 27832845Gonska B, Seeger J, Kessler M, von Keil A, Rottbauer W, Wohrle J. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve. Clin Res Cardiol. 2017 Aug;106(8):590-597. doi: 10.1007/s00392-017-1093-2. Epub 2017 Mar 10.
PubMed 28283746Husser O, Pellegrini C, Kessler T, Burgdorf C, Thaller H, Mayr NP, Kasel AM, Kastrati A, Schunkert H, Hengstenberg C. Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve. JACC Cardiovasc Interv. 2016 Feb 8;9(3):244-254. doi: 10.1016/j.jcin.2015.09.036.
PubMed 26847116Schwerg M, Fulde F, Dreger H, Poller WC, Stangl K, Laule M. Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI. J Interv Cardiol. 2016 Aug;29(4):370-4. doi: 10.1111/joic.12302. Epub 2016 May 31.
PubMed 27240558Fujita B, Kutting M, Seiffert M, Scholtz S, Egron S, Prashovikj E, Borgermann J, Schafer T, Scholtz W, Preuss R, Gummert J, Steinseifer U, Ensminger SM. Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1385-1393. doi: 10.1093/ehjci/jev343. Epub 2016 Jan 12.
PubMed 26758411
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. 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
- NCT03715894
- Acronym / sponsor ID
- Conduct-pro / Conduct prospective
- 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
- 300 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 23 Oct 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 procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI
Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. Additional assessment of calcification using a CT data core lab. Statistical analysis of the dataset obtained 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
- patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for
- procedural variables (e.g. implantation hieght, valve size etc.) that should be considered to perform as safe and minimal invasive procedure as possible.
Prior Research To date there are 8 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV.
These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% based on patient numbers between 131 and 335 patients.
These analyses resulted in the identification of pre-existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, prolonged QRS duration or short membranous septum as patient related factors associated with PPI during Edwards SAPIEN 3 THV TAVI. Similarly, procedural variables such as implantation height /oversizing as procedure related variables are associated with PPI after TAVI.
The literature regarding procedure related variables associated with permanent pacemaker implantation in patients receiving an Edwards SAPIEN 3 valve shows multivariable analyses with slightly different views to the requested procedural variables.
Tarantini et al. suggest a higher valve implantation (ventricular ratio >60/40 at qualitative assessment or depth <8mm at qualitative assessment). A similar outcome was reported by De Torres-Alba et al.. Due to the longer stent of the SAPIEN 3 they suggest an even higher implantation, intending a shorter extension of the stent into the LVOT by increasing the percentage of the stent in the aorta to >70%. Schwerg et al. compare the PPI rate in "low implantation" with "high implantation" independently from the patients pre-existing conduction disturbances, and suggest to minimize the risk of PPI by choosing a higher implantation technique with the central marker 2 mm or more over the annular plane.
Furthermore Mauri et al. encourage to choose a implantation height of <25.5% (Implantation height was expressed as the percentage of the ventricular part of the stent frame in relation to the overall stent frame length).
Another procedural factor is found to be aortic annulus oversizing ratios which are known to prevent paravalvular leakage. Leber et al. show the rate of post-procedural permanent pacemakers tended to be lower in patients with <15% oversizing compared to those with >25% oversizing for Edwards Sapien XT. Using SAPIEN 3 valves Husser et al. show a higher PPI rate in patients with out of range oversizing.
Gonska et al. conclude that neither implantation height nor oversizing has an effect on PPI rate.
On the other hand the need for pre-dilatation by balloon valvuloplasty and post-implant dilatation have not been identified as potential contributing factors for PPI as it is believed the impact of the dilatation on the conduction tissue is transient and short lived.
Nevertheless, pre- and post-dilatation should be further considered and analysed.
Hypothetically, also the following procedural parameters, which have not been investigated in detail so far, could be risks for PPIs: Stiff guidewire use or a no touch policy and should be considered in this research.
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 with PPI and the unexplained differences in the number and type of variables identified.
Aims This registry aims to assess procedural variables and to verify risk factors in a prospective multicenter registry.
To identify predictors of PPI patients with a high risk for PPI will be preferably included to increase the power compared to pre-existing database analyses from single centres. The target is to identify general procedural predictors and to verify risk factors of PPI post TAVI with the Edwards SAPIEN 3 valve which when identified and avoided will reduce the need of PPI in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aortic stenosis | – | Procedure: transcatheter valve implantationPatients receiving Edwards SAPIEN 3 aortic transcatheter valve Implantation, who are with a high risk for PPI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing transfemoral transcatheter valve implantation with the SAPIEN 3 valve with at least one identified risk factor for PPI
Key inclusion criteria (2 listed)
- Patients undergoing transfemoral SAPIEN 3 implantation because of aortic stenosis,
- at least 1 of the identified risk factors from the retrospective part to ensure a minimum risk of 33% for PPI (presumed: pre-existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, QRS duration or short membranous septum,to be confirmed);
Key exclusion criteria (3 listed)
- with indications for pacemaker implantation prior to TAVI
- valve in valve implantation or
- without informed consent
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 permanent pacemaker implantation after TAVI in high risk patients
Time frame: 1 year
Need for permanent pacemaker implantation after TAVI in high risk patients.
4 secondary outcomes
Implantation depth
Time frame: up to 30 days after intervention
Valve sizing
Time frame: up to 30 days after intervention
Dilatation
Time frame: 1 year
Expiration data
Time frame: 2 years
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 15 Jun 2023.
- Background: PubMed 29404357Bob-Manuel T, Nanda A, Latham S, Pour-Ghaz I, Skelton WP 4th, Khouzam RN. Permanent pacemaker insertion in patients with conduction abnormalities post transcatheter aortic valve replacement: a review and proposed guidelines. Ann Transl Med. 2018 Jan;6(1):11. doi: 10.21037/atm.2017.10.21.
- Background: PubMed 27017367De Torres-Alba F, Kaleschke G, Diller GP, Vormbrock J, Orwat S, Radke R, Reinke F, Fischer D, Reinecke H, Baumgartner H. Changes in the Pacemaker Rate After Transition From Edwards SAPIEN XT to SAPIEN 3 Transcatheter Aortic Valve Implantation: The Critical Role of Valve Implantation Height. JACC Cardiovasc Interv. 2016 Apr 25;9(8):805-813. doi: 10.1016/j.jcin.2015.12.023. Epub 2016 Mar 23.
- Background: PubMed 28412434Maeno Y, Abramowitz Y, Kawamori H, Kazuno Y, Kubo S, Takahashi N, Mangat G, Okuyama K, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.
- Background: PubMed 25405801Tarantini G, Mojoli M, Purita P, Napodano M, D'Onofrio A, Frigo A, Covolo E, Facchin M, Isabella G, Gerosa G, Iliceto S. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015 Jul;11(3):343-50. doi: 10.4244/EIJY14M11_06.
- Background: PubMed 27832845Mauri V, Reimann A, Stern D, Scherner M, Kuhn E, Rudolph V, Rosenkranz S, Eghbalzadeh K, Friedrichs K, Wahlers T, Baldus S, Madershahian N, Rudolph TK. Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2200-2209. doi: 10.1016/j.jcin.2016.08.034.
- Background: PubMed 28283746Gonska B, Seeger J, Kessler M, von Keil A, Rottbauer W, Wohrle J. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve. Clin Res Cardiol. 2017 Aug;106(8):590-597. doi: 10.1007/s00392-017-1093-2. Epub 2017 Mar 10.
- Background: PubMed 26847116Husser O, Pellegrini C, Kessler T, Burgdorf C, Thaller H, Mayr NP, Kasel AM, Kastrati A, Schunkert H, Hengstenberg C. Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve. JACC Cardiovasc Interv. 2016 Feb 8;9(3):244-254. doi: 10.1016/j.jcin.2015.09.036.
- Background: PubMed 27240558Schwerg M, Fulde F, Dreger H, Poller WC, Stangl K, Laule M. Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI. J Interv Cardiol. 2016 Aug;29(4):370-4. doi: 10.1111/joic.12302. Epub 2016 May 31.
- Background: PubMed 26758411Fujita B, Kutting M, Seiffert M, Scholtz S, Egron S, Prashovikj E, Borgermann J, Schafer T, Scholtz W, Preuss R, Gummert J, Steinseifer U, Ensminger SM. Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1385-1393. doi: 10.1093/ehjci/jev343. Epub 2016 Jan 12.
- 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
5 sites in 3 countries: 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 5 sites in 3 countries.
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 2 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands, Sweden. 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 permanent pacemaker implantation after TAVI in high risk patients (time frame: 1 year). 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 NCT03715894, which also lists 9 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 15 Jun 2023.