Aortic Valve Disease MixedNCT01368250
SwissTAVI Registry
An observational study of Aortic Valve Disease Mixed, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease Mixed
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2011to May 2025
- 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 with aortic valve disease or degenerated aortic bioprosthesis scheduled to undergo transcatheter aortic valve implantation (TAVI) using commercially available devices with CE approval are eligible for enrollment in the registry. The TAVI procedure can be performed using all available access routes.
Who may be able to join
- Native aortic valve stenosis
- Native aortic valve regurgitation
- Degenerated aortic bioprosthesis requiring treatment
Who cannot join
- Patients refuses informed consent to participate in the registry
- Contraindication for TAVI
- High probability of non-adherence to the follow up - requirements
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Department of Cardiology
Bern, 3010
Stefan Stortecky, MD, 0041 31 632 21 11, stefan.stortecky@insel.ch
Stefan Stortecky, MD
- Recruiting
Department of Cardiology
Bern, 3010
Stephan Windecker, MD, 0041 31 632 21 11, stephan.windecker@insel.ch
About this study
Official title: SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.
Read the detailed description
The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population.
Methods
This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.
- Conditions
- Aortic Valve Disease Mixed
- Being tested
- Transcatheter Aortic Valve Implantation
- Keywords
- Aortic valve, Heart valve, VARC, Transcatheter, Minimal-invasive, TAVI, TAVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationProcedure or surgery
Minimal Invasive Implantation of a biological prosthesis in Aortic Position
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with native aortic stenosis undergoing TAVI Receives: Procedure: Transcatheter Aortic Valve Implantation | |
| 2 | Patients with native aortic regurgitation undergoing TAVI | |
| 3 | Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Composed by:
- death
- stroke
- aortic valve re-intervention
- structural valve deterioration
- myocardial Infarction
Measured: 1 year
Secondary outcomes (3)
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Composed by:
- death
- stroke
- aortic valve re-intervention
- myocardial Infarction
- kidney injury
- access related complications
- pacemaker requirements
Measured: 30days
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Composed by:
- death
- stroke
- aortic valve re-intervention
- structural valve deterioration
Measured: 5 years
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Composed by:
- death
- stroke
- aortic valve re-intervention
- structural valve deterioration
Measured: 10 years , 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve Disease MixedStudies 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Stortecky, MD, Study chair, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368250
- Sponsor's protocol ID
- 056/11
- Status last verified
- May 2024
- First submitted
- 6 Jun 2011
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tomii D, Alaour B, Heg D, Okuno T, Nakase M, Samim D, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp calcification. Am Heart J. 2026 Feb;292:107279. doi: 10.1016/j.ahj.2025.09.011. Epub 2025 Sep 18.
PubMed 40975195Badertscher P, Stortecky S, Serban T, Knecht S, Heg D, Tueller D, Jeger R, Reuthebuch O, Muller O, Toggweiler S, Wenaweser P, Huber C, Roffi M, Ferrari E, Reichlin T, Nestelberger T, Mahfoud F, Kuhne M, Sticherling C; SwissTAVI Investigators. Long-Term Outcomes of Patients Requiring Pacemaker Implantation After Transcatheter Aortic Valve Replacement: The SwissTAVI Registry. JACC Cardiovasc Interv. 2025 May 12;18(9):1163-1171. doi: 10.1016/j.jcin.2025.03.028. Epub 2025 Apr 1.
PubMed 40368460Nakase M, Draxler DF, Tomii D, Heg D, Okuno T, Samim D, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Incidence, predictors and clinical impact of upper gastrointestinal bleeding after transcatheter aortic valve replacement. Heart. 2025 Nov 12;111(23):1149-1155. doi: 10.1136/heartjnl-2024-325359.
PubMed 40348411Tomii D, Heg D, Nakase M, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Flow Status-Based Predicted Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. Struct Heart. 2024 Dec 6;9(4):100379. doi: 10.1016/j.shj.2024.100379. eCollection 2025 Apr.
PubMed 40321306Hodel C, Moccetti F, Brunner S, Sandoz V, Loretz L, Wolfrum M, Toggweiler S. Long-Term Outcomes After Transcatheter Aortic Valve Replacement Complicated by New-Onset Persistent Left Bundle Branch Block. Catheter Cardiovasc Interv. 2025 Jun;105(7):1545-1551. doi: 10.1002/ccd.31491. Epub 2025 Mar 13.
PubMed 40079520Nakase M, Tomii D, Maznyczka A, Heg D, Okuno T, Samim D, Stortecky S, Lanz J, Reineke D, Windecker S, Pilgrim T. Five-year outcomes with self-expanding versus balloon-expandable TAVI in patients with left ventricular systolic dysfunction. Am Heart J. 2025 Feb;280:18-29. doi: 10.1016/j.ahj.2024.10.018. Epub 2024 Nov 12.
PubMed 39536846Nakase M, Tomii D, Samim D, Grani C, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Impact of Severity and Extent of Iliofemoral Atherosclerosis on Clinical Outcomes in Patients Undergoing TAVR. JACC Cardiovasc Interv. 2024 Oct 28;17(20):2353-2363. doi: 10.1016/j.jcin.2024.07.009. Epub 2024 Oct 9.
PubMed 39387783Tomii D, Heg D, Lanz J, Nakase M, Samim D, Stortecky S, Reineke D, Windecker S, Pilgrim T. Renin-Angiotensin System Inhibition in Patients With Myocardial Injury Complicating Transcatheter Aortic Valve Replacement. JACC Adv. 2024 Aug 16;3(9):101212. doi: 10.1016/j.jacadv.2024.101212. eCollection 2024 Sep.
PubMed 39253713Tomii D, Okuno T, Nakase M, Praz F, Stortecky S, Reineke D, Windecker S, Lanz J, Pilgrim T. Renin-Angiotensin System Inhibition and Cardiac Damage in Patients Undergoing Transcatheter Aortic Valve Replacement. Can J Cardiol. 2024 Dec;40(12):2592-2602. doi: 10.1016/j.cjca.2024.07.019. Epub 2024 Jul 25.
PubMed 39067618Brunner S, Moccetti F, Loretz L, Conrad N, Bossard M, Attinger-Toller A, Kurmann R, Cuculi F, Wolfrum M, Toggweiler S. The impact of elevated C-reactive protein levels on long-term outcomes of patients undergoing transcatheter aortic valve replacement. Cardiovasc Revasc Med. 2025 Jan;70:71-75. doi: 10.1016/j.carrev.2024.07.002. Epub 2024 Jul 6.
PubMed 38987046Nakase M, Tomii D, Maznyczka A, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Sex-Specific Differences in Upstream Cardiac Damage in Patients With Aortic Stenosis Undergoing TAVR. JACC Cardiovasc Interv. 2024 May 27;17(10):1252-1264. doi: 10.1016/j.jcin.2024.03.031.
PubMed 38811107Nakase M, Tomii D, Heg D, Praz F, Stortecky S, Reineke D, Samim D, Lanz J, Windecker S, Pilgrim T. Long-Term Impact of Cardiac Damage Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2024 Apr 22;17(8):992-1003. doi: 10.1016/j.jcin.2024.02.011.
PubMed 38658128Alaour B, Ferrari E, Heg D, Tueller D, Pilgrim T, Muller O, Noble S, Jeger R, Reuthebuch O, Toggweiler S, Templin C, Wenaweser P, Nietlispach F, Taramasso M, Huber C, Roffi M, Windecker S, Stortecky S. Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2024 Feb 12;17(3):405-418. doi: 10.1016/j.jcin.2023.11.038.
PubMed 38355269Okuno T, Alaour B, Heg D, Tueller D, Pilgrim T, Muller O, Noble S, Jeger R, Reuthebuch O, Toggweiler S, Ferrari E, Templin C, Wenaweser P, Nietlispach F, Taramasso M, Huber C, Roffi M, Windecker S, Stortecky S. Long-Term Risk of Stroke After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2986-2996. doi: 10.1016/j.jcin.2023.10.021.
PubMed 38151313Tomii D, Okuno T, Heg D, Nakase M, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Long-term outcomes of measured and predicted prosthesis-patient mismatch following transcatheter aortic valve replacement. EuroIntervention. 2023 Nov 17;19(9):746-756. doi: 10.4244/EIJ-D-23-00456.
PubMed 37622754
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT01368250
- Acronym / sponsor ID
- 056/11
- Conditions
- Aortic Valve Disease Mixed
- Keywords
- Aortic valve, Heart valve, VARC, Transcatheter, Minimal-invasive, TAVI, TAVR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Jun 2011 (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.
The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.
Detailed description
The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population.
Methods
This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Transcatheter Aortic Valve ImplantationPatients with native aortic stenosis undergoing TAVI |
| 2 | – | –Patients with native aortic regurgitation undergoing TAVI |
| 3 | – | –Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aortic valve disease or degenerated aortic bioprosthesis scheduled to undergo transcatheter aortic valve implantation (TAVI) using commercially available devices with CE approval are eligible for enrollment in the registry. The TAVI procedure can be performed using all available access routes.
Key inclusion criteria (3 listed)
- Native aortic valve stenosis
- Native aortic valve regurgitation
- Degenerated aortic bioprosthesis requiring treatment
Key exclusion criteria (3 listed)
- Patients refuses informed consent to participate in the registry
- Contraindication for TAVI
- High probability of non-adherence to the follow up - requirements
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 Aortic Valve ImplantationMinimal Invasive Implantation of a biological prosthesis in Aortic Position | Procedure or surgery | 1 |
Primary outcome
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time frame: 1 year
Composed by: * death * stroke * aortic valve re-intervention * structural valve deterioration * myocardial Infarction
3 secondary outcomes
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time frame: 30days
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time frame: 5 years
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time frame: 10 years , 15 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 40975195Tomii D, Alaour B, Heg D, Okuno T, Nakase M, Samim D, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp calcification. Am Heart J. 2026 Feb;292:107279. doi: 10.1016/j.ahj.2025.09.011. Epub 2025 Sep 18.
- Derived from this study: PubMed 40368460Badertscher P, Stortecky S, Serban T, Knecht S, Heg D, Tueller D, Jeger R, Reuthebuch O, Muller O, Toggweiler S, Wenaweser P, Huber C, Roffi M, Ferrari E, Reichlin T, Nestelberger T, Mahfoud F, Kuhne M, Sticherling C; SwissTAVI Investigators. Long-Term Outcomes of Patients Requiring Pacemaker Implantation After Transcatheter Aortic Valve Replacement: The SwissTAVI Registry. JACC Cardiovasc Interv. 2025 May 12;18(9):1163-1171. doi: 10.1016/j.jcin.2025.03.028. Epub 2025 Apr 1.
- Derived from this study: PubMed 40348411Nakase M, Draxler DF, Tomii D, Heg D, Okuno T, Samim D, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Incidence, predictors and clinical impact of upper gastrointestinal bleeding after transcatheter aortic valve replacement. Heart. 2025 Nov 12;111(23):1149-1155. doi: 10.1136/heartjnl-2024-325359.
- Derived from this study: PubMed 40321306Tomii D, Heg D, Nakase M, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Flow Status-Based Predicted Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. Struct Heart. 2024 Dec 6;9(4):100379. doi: 10.1016/j.shj.2024.100379. eCollection 2025 Apr.
- Derived from this study: PubMed 40079520Hodel C, Moccetti F, Brunner S, Sandoz V, Loretz L, Wolfrum M, Toggweiler S. Long-Term Outcomes After Transcatheter Aortic Valve Replacement Complicated by New-Onset Persistent Left Bundle Branch Block. Catheter Cardiovasc Interv. 2025 Jun;105(7):1545-1551. doi: 10.1002/ccd.31491. Epub 2025 Mar 13.
- Derived from this study: PubMed 39536846Nakase M, Tomii D, Maznyczka A, Heg D, Okuno T, Samim D, Stortecky S, Lanz J, Reineke D, Windecker S, Pilgrim T. Five-year outcomes with self-expanding versus balloon-expandable TAVI in patients with left ventricular systolic dysfunction. Am Heart J. 2025 Feb;280:18-29. doi: 10.1016/j.ahj.2024.10.018. Epub 2024 Nov 12.
- Derived from this study: PubMed 39387783Nakase M, Tomii D, Samim D, Grani C, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Impact of Severity and Extent of Iliofemoral Atherosclerosis on Clinical Outcomes in Patients Undergoing TAVR. JACC Cardiovasc Interv. 2024 Oct 28;17(20):2353-2363. doi: 10.1016/j.jcin.2024.07.009. Epub 2024 Oct 9.
- Derived from this study: PubMed 39253713Tomii D, Heg D, Lanz J, Nakase M, Samim D, Stortecky S, Reineke D, Windecker S, Pilgrim T. Renin-Angiotensin System Inhibition in Patients With Myocardial Injury Complicating Transcatheter Aortic Valve Replacement. JACC Adv. 2024 Aug 16;3(9):101212. doi: 10.1016/j.jacadv.2024.101212. eCollection 2024 Sep.
- Derived from this study: PubMed 39067618Tomii D, Okuno T, Nakase M, Praz F, Stortecky S, Reineke D, Windecker S, Lanz J, Pilgrim T. Renin-Angiotensin System Inhibition and Cardiac Damage in Patients Undergoing Transcatheter Aortic Valve Replacement. Can J Cardiol. 2024 Dec;40(12):2592-2602. doi: 10.1016/j.cjca.2024.07.019. Epub 2024 Jul 25.
- Derived from this study: PubMed 38987046Brunner S, Moccetti F, Loretz L, Conrad N, Bossard M, Attinger-Toller A, Kurmann R, Cuculi F, Wolfrum M, Toggweiler S. The impact of elevated C-reactive protein levels on long-term outcomes of patients undergoing transcatheter aortic valve replacement. Cardiovasc Revasc Med. 2025 Jan;70:71-75. doi: 10.1016/j.carrev.2024.07.002. Epub 2024 Jul 6.
- Derived from this study: PubMed 38811107Nakase M, Tomii D, Maznyczka A, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Sex-Specific Differences in Upstream Cardiac Damage in Patients With Aortic Stenosis Undergoing TAVR. JACC Cardiovasc Interv. 2024 May 27;17(10):1252-1264. doi: 10.1016/j.jcin.2024.03.031.
- Derived from this study: PubMed 38658128Nakase M, Tomii D, Heg D, Praz F, Stortecky S, Reineke D, Samim D, Lanz J, Windecker S, Pilgrim T. Long-Term Impact of Cardiac Damage Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2024 Apr 22;17(8):992-1003. doi: 10.1016/j.jcin.2024.02.011.
Related trials for Aortic Valve Disease Mixed
Active, not recruitingObservational study
Identification of Genetic Causes of Calcific Aortic Valve Disease
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Recruiting
J-Valve Transfemoral Pivotal Study
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Not yet recruiting
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Recruiting
Physical Activity and Community EmPOWERment Project
Intellectual Disability, Neurodevelopmental Disorders
RecruitingObservational study
Outcomes in Moderate Mixed Aortic Valve Disease
Mixed Aortic Valve Disease
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.
Stefan Stortecky, MD study chair
Bern University Hospital
2 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 Disease Mixed, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Stortecky, MD (0041 31 632 83 52, stefan.stortecky@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) (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 NCT01368250, which also lists 46 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 23 May 2024.