Aortic StenosisCHOICENCT01645202
A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial
A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Aortic Stenosis, run by Segeberger Kliniken GmbH at 1 site in Germany.
Trial summary
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Dec 2018
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
- Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
- Age > 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
- Native aortic valve annulus measuring 20-25 mm
- Patients must be suitable for a transfemoral vascular access
- The patient signing a written informed consent prior to intervention
Who cannot join
- Life expectancy < 12 months due to co-morbid conditions
- Native aortic valve annulus < 20 mm and > 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
- Pre-existing aortic bioprosthesis
- Cardiogenic shock or hemodynamic instability
- History of, or active endocarditis
- Contraindications for a transfemoral access
Show all 11Show fewer
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
- Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
- Active infection requiring antibiotic treatment
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment
- Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Segeberger Kliniken GmbH / Herzzentrum
Bad Segeberg, Schleswig-Holstein, 23795
About this study
Official title: A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.
Read the detailed description
Study design: randomized open-label multicenter
Primary endpoint:
'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:
- Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,
- Correct position of the device in the proper anatomical location,
- Intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and
- Only one valve implanted in the proper anatomical location.
Secondary endpoints:
- 30-day-combined safety endpoint which is a combined endpoint defined by VARC as:
- All cause mortality,
- Major stroke,
- Life threatening (or disabling) bleeding,
- Acute kidney injury-Stage 3 (including renal replacement therapy),
- Periprocedural myocardial infarction,
- Major vascular complications and
- Repeat procedure for valve-related dysfunction (surgical or interventional therapy). *
- Combined efficacy endpoint at 1 year which is a composite endpoint defined by VARC as:
- All cause mortality between 30 days and one year,
- Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and
- Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic valve AR). *
- Cardiovascular mortality as defined by VARC at 1 month, 6 and 12 months. *
- Major adverse cardiovascular and cerebrovascular events (MACCE): myocardial infarction, cardiac or vascular surgery and stroke at 30 days, 6 \& 12 months.
- Rehospitalization for heart failure at 12 months
- Quality of life (assessed with the Euro5Qual-questionnaire) at 12 months
- NYHA-class improvement at 30 days, 6 and 12 months
- Vascular complication as defined by VARC at 30 days.
- Post-procedural pacemaker implantation at 1 month
- Major or minor Bleeding at 30 days as defined be VARC.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Aortic stenosis, TAVI, Device success, Aortic regurgitation
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Procedure or surgery
Also called Transcatheter Aortic Valve Replacement (TAVR)
Comparison of different types of valves
| Study group | Role | What they receive |
|---|---|---|
| TAVI with Edwards Sapien XT valve | Active comparator | Not described Receives: Procedure: Transcatheter Aortic Valve Implantation (TAVI) |
| TAVI with Medtronic CoreValve | Active comparator | Not described Receives: Procedure: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
'Device success' as recently defined by the Valve Academic Research Consortium
Device success is a 'technical' composite endpoint including successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, correct position of the device in the proper anatomical location, intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and only one valve implanted in the proper anatomical location.
Measured: Immediately after the procedure
Secondary outcomes (2)
VARC-defined combined safety endpoint
Combined endpoint defined by VARC as: 1) All cause mortality, 2) Major stroke, 3) Life threatening (or disabling) bleeding, 4) Acute kidney injury-Stage 3 (including renal replacement therapy), 5) Periprocedural myocardial infarction, 6) Major vascular complications and 7) Repeat procedure for valve-related dysfunction (surgical or interventional therapy).
Measured: 30 days
VARC-defined combined efficacy endpoint
A composite endpoint defined by VARC as: 1) All cause mortality between 30 days and one year, 2) Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and 3) Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic valve AR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aortic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Segeberger Kliniken GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Abdel-Wahab, MD, Principal investigator, Herzzentrum, Segeberger Kliniken, Bad Segeberg, GermanyGert Richardt, MD, Study chair, Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645202
- Sponsor's protocol ID
- SK 107 -- 012/12 (II)
- Acronym
- CHOICE
- Status last verified
- Feb 2019
- First submitted
- 6 Jun 2012
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol. 2007 Jul 3;50(1):69-76. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.
PubMed 17601548Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.
PubMed 22019110Abdel-Wahab M, Zahn R, Horack M, Gerckens U, Schuler G, Sievert H, Eggebrecht H, Senges J, Richardt G; German transcatheter aortic valve interventions registry investigators. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart. 2011 Jun;97(11):899-906. doi: 10.1136/hrt.2010.217158. Epub 2011 Mar 12.
PubMed 21398694Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.
PubMed 21050971Abdel-Wahab M, Landt M, Neumann FJ, Massberg S, Frerker C, Kurz T, Kaur J, Toelg R, Sachse S, Jochheim D, Schafer U, El-Mawardy M, Robinson DR, Richardt G; CHOICE Investigators. 5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 May 11;13(9):1071-1082. doi: 10.1016/j.jcin.2019.12.026. Epub 2020 Apr 15.
PubMed 32305398Abdel-Wahab M, Neumann FJ, Mehilli J, Frerker C, Richardt D, Landt M, Jose J, Toelg R, Kuck KH, Massberg S, Robinson DR, El-Mawardy M, Richardt G; CHOICE Investigators. 1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):791-800. doi: 10.1016/j.jacc.2015.06.026.
PubMed 26271061Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tolg R, Zachow D, Guerra E, Massberg S, Schafer U, El-Mawardy M, Richardt G; CHOICE investigators. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA. 2014 Apr 16;311(15):1503-14. doi: 10.1001/jama.2014.3316.
PubMed 24682026
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)
- ClinicalTrials.gov ID
- NCT01645202
- Acronym / sponsor ID
- CHOICE / SK 107 -- 012/12 (II)
- Conditions
- Aortic Stenosis
- Keywords
- Aortic stenosis, TAVI, Device success, Aortic regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Segeberger Kliniken GmbHUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Jul 2012 (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.
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.
Detailed description
Study design: randomized open-label multicenter
Primary endpoint:
'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:
- Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,
- Correct position of the device in the proper anatomical location,
- Intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and
- Only one valve implanted in the proper anatomical location.
Secondary endpoints:
- 30-day-combined safety endpoint which is a combined endpoint defined by VARC as:
- All cause mortality,
- Major stroke,
- Life threatening (or disabling) bleeding,
- Acute kidney injury-Stage 3 (including renal replacement therapy),
- Periprocedural myocardial infarction,
- Major vascular complications and
- Repeat procedure for valve-related dysfunction (surgical or interventional therapy). *
- Combined efficacy endpoint at 1 year which is a composite endpoint defined by VARC as:
- All cause mortality between 30 days and one year,
- Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and
- Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic valve AR). *
- Cardiovascular mortality as defined by VARC at 1 month, 6 and 12 months. *
- Major adverse cardiovascular and cerebrovascular events (MACCE): myocardial infarction, cardiac or vascular surgery and stroke at 30 days, 6 \& 12 months.
- Rehospitalization for heart failure at 12 months
- Quality of life (assessed with the Euro5Qual-questionnaire) at 12 months
- NYHA-class improvement at 30 days, 6 and 12 months
- Vascular complication as defined by VARC at 30 days.
- Post-procedural pacemaker implantation at 1 month
- Major or minor Bleeding at 30 days as defined be VARC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI with Edwards Sapien XT valve | Active comparator | Procedure: Transcatheter Aortic Valve Implantation (TAVI) |
| TAVI with Medtronic CoreValve | Active comparator | Procedure: Transcatheter Aortic Valve Implantation (TAVI) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
- Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
- Age > 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
- Native aortic valve annulus measuring 20-25 mm
- Patients must be suitable for a transfemoral vascular access
Key exclusion criteria (11 listed)
- Life expectancy < 12 months due to co-morbid conditions
- Native aortic valve annulus < 20 mm and > 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
- Pre-existing aortic bioprosthesis
- Cardiogenic shock or hemodynamic instability
- History of, or active endocarditis
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 Implantation (TAVI)Also: Transcatheter Aortic Valve Replacement (TAVR)Comparison of different types of valves | Procedure or surgery | TAVI with Edwards Sapien XT valve, TAVI with Medtronic CoreValve |
Primary outcome
'Device success' as recently defined by the Valve Academic Research Consortium
Time frame: Immediately after the procedure
Device success is a 'technical' composite endpoint including successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, correct position of the device in the proper anatomical location, intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and only one valve implanted in the proper anatomical location.
2 secondary outcomes
VARC-defined combined safety endpoint
Time frame: 30 days
VARC-defined combined efficacy endpoint
Time frame: 1 year
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 26 Jul 2019.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 17601548Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol. 2007 Jul 3;50(1):69-76. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.
- Background: PubMed 22019110Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.
- Background: PubMed 21398694Abdel-Wahab M, Zahn R, Horack M, Gerckens U, Schuler G, Sievert H, Eggebrecht H, Senges J, Richardt G; German transcatheter aortic valve interventions registry investigators. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart. 2011 Jun;97(11):899-906. doi: 10.1136/hrt.2010.217158. Epub 2011 Mar 12.
- Background: PubMed 21050971Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.
- Derived from this study: PubMed 32305398Abdel-Wahab M, Landt M, Neumann FJ, Massberg S, Frerker C, Kurz T, Kaur J, Toelg R, Sachse S, Jochheim D, Schafer U, El-Mawardy M, Robinson DR, Richardt G; CHOICE Investigators. 5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 May 11;13(9):1071-1082. doi: 10.1016/j.jcin.2019.12.026. Epub 2020 Apr 15.
- Derived from this study: PubMed 26271061Abdel-Wahab M, Neumann FJ, Mehilli J, Frerker C, Richardt D, Landt M, Jose J, Toelg R, Kuck KH, Massberg S, Robinson DR, El-Mawardy M, Richardt G; CHOICE Investigators. 1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):791-800. doi: 10.1016/j.jacc.2015.06.026.
- Derived from this study: PubMed 24682026Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tolg R, Zachow D, Guerra E, Massberg S, Schafer U, El-Mawardy M, Richardt G; CHOICE investigators. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA. 2014 Apr 16;311(15):1503-14. doi: 10.1001/jama.2014.3316.
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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.
Mohamed Abdel-Wahab, MD principal investigator
Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
Gert Richardt, MD study chair
Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Aortic Stenosis, run by Segeberger Kliniken GmbH 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 6 inclusion and 11 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 26 Jul 2019. 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?
'Device success' as recently defined by the Valve Academic Research Consortium (time frame: Immediately after the procedure). 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 NCT01645202, which also lists 8 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 26 Jul 2019.