Bicuspid Aortic Valve (BAV)CONTOURNCT06869954
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
A study testing Internal HAART 200 annuloplasty device and double external ring annuloplasty in people with Bicuspid Aortic Valve (BAV) and Aortic Regurgitation Disease, run by University Hospital Augsburg at 4 sites in Germany.
Trial summary
Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bicuspid Aortic Valve (BAV), Aortic Regurgitation Disease
- What is being tested?
- Internal HAART 200 annuloplasty device and double external ring annuloplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesGermany
- Study dates
- 21 May 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation < 170 degree) [14]
- Severe aortic regurgitation (vena contracta (vc) > 6mm and/or pressure half-time (PHT) < 200 ms and/or effective regurgitant orifice area (EROA) > 30 mm2 and/or regurgitant volume (RV) > 60 ml/beat and/or left ventricular end-systolic diameter (LVESD) > 50mm (or indexed LVESD > 20mm/m2 BSA) and/or regurgitation fraction (RF) in cardiothoracic MRI > 40%) (at least one parameter is required) [15]
- Isolated aortic valve surgery or concomitant procedure (including CABG and/or mitral/tricuspid valve surgery and/or ascending aortic surgery)
- Willingness to participate and written informed consent
- Age at surgery > 18 years
Who cannot join
- Moderate/severe BAV stenosis (pmean > 20mmHg)
- Moderate/severe BAV cusp calcifications extending beyond the raphe region and/or necessitating patch implantation (deemed irreparable based on preoperative TOE (as by decision of the operating surgeon)
- Concomitant aortic root aneurysm > 45mm requiring simultaneous aortic root surgery [16]
- Acute/subacute BAV endocarditis
- Contraindication to MRI
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, Bavaria, 86156
Evaldas Girdauskas, Prof, evaldas.girdauskas@uk-augsburg.de
- Not yet recruiting
University Heart and Vascular Center Frankfurt
Frankfurt am Main, Hesse, 60598
Thomas Walther, Prof.
- Recruiting
Medical Center Hamburg-Eppendorf
Hamburg, 20246
Johannes Petersen, Dr. med., joh.petersen@uke.de
- Not yet recruiting
Heart Center Leipzig
Leipzig, Saxony, 04289
Michael Borger, Prof.
About this study
Official title: Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial
Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. The lack of sufficient standardization remains the main limitation of current repair techniques, resulting in an increased risk of AR recurrence and reoperation. The most controversial issue is the stabilization of the BAV annulus. The CONTOUR trial aims to compare two different BAV annuloplasty concepts in a prospective randomized study.
Methods: CONTOUR is a multicenter, randomized controlled trial designed to enroll 100 consecutive BAV patients with AR across four sites in Germany. BAV AR patients with an asymmetric configuration and without concomitant root aneurysm will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (i.e., INTERNAL group) (n=50) or external annuloplasty (i.e., double external ring annuloplasty) in the EXTERNAL group (n=50). 4D flow MRI will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of hemodynamic profiles (i.e., flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary endpoints will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up.
Discussion: The CONTOUR trial is designed to test the hypothesis that an internal annuloplasty device, creating a completely symmetric post-repair BAV geometry, achieves superior aortic valve repair outcomes compared to external annuloplasty. If our hypothesis is confirmed, our study will significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.
- Being tested
- Internal HAART 200 annuloplasty device, double external ring annuloplasty
- Keywords
- aortic regurgitation, aortic valve repair, annuloplasty, bicuspid aortic valve
- Medical subject headings
- Bicuspid Aortic Valve Disease, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal HAART 200 annuloplasty deviceDevice
For the INTERNAL group, the HAART 200 internal annuloplasty ring (CorCym, London, UK), specifically designed for BAV morphology, will be used for all patients. Intraoperative sizing for the internal ring is based on the geometric orientation and size of the non-fused cusp. A standard ball sizer is used for the measurement of the non-fused cusp to assess commissural orientation and surface area of the non-fused cusp. Sizing typically results in values of 23mm or 25mm, with other sizes being very rare. Both commissural posts of the internal annuloplasty ring are fixed using two subcommissural sutures [10]. A modified technique for placement of transannular looping sutures will be used to secure the internal ring in the subannular position, as recently published [21]. Cusp maneuvers (i.e., shaving, thinning of the raphe, central plication sutures) will be performed to achieve an effective height of 8-10 mm. When indicated (i.e., for ascending aortic diameter > 45mm or aiming to achieve th
double external ring annuloplastyDevice
For the EXTERNAL group, all study patients will undergo double external Dacron ring annuloplasty by simultaneous stabilization of the basal virtual ring and the STJ [22]. The surgical technique of double external annuloplasty, detailed by the Lansac group [22], involves aortic annulus sizing with a Hegar dilator to select the sizes of the external subannular annuloplasty ring and STJ ring (same size). After deep dissection of the aortic root, 6-7 2-0 pledgeted U sutures are placed circumferentially at the level of the virtual basal ring for external subannular ring implantation. Cusp maneuvers are performed similar to those in the INTERNAL group. STJ stabilization is achieved using an external STJ ring or ascending aortic replacement with a vascular tube graft (e.g., in cases with a high offspring of the right coronary artery). Treatment of the tubular ascending aorta is identical to the INTERNAL group.
| Study group | Role | What they receive |
|---|---|---|
| INTERNAL Group | Active comparator | For the INTERNAL group, the HAART 200 internal annuloplasty ring (CorCym, London, UK), specifically designed for BAV morphology, will be used for all patients. Intraoperative sizing for the internal ring is based on the geometric orientation and size of the non-fused cusp. A standard ball sizer is used for the measurement of the non-fused cusp to assess commissural orientation and surface area of the non-fused cusp. Sizing typically results in values of 23mm or 25mm, with other sizes being very rare. Both commissural posts of the internal annuloplasty ring are fixed using two subcommissural sutures [10]. A modified technique for placement of transannular looping sutures will be used to secure the internal ring in the subannular position, as recently published [21]. Cusp maneuvers (i.e., shaving, thinning of the raphe, central plication sutures) will be performed to achieve an effective height of 8-10 mm. When indicated (i.e., for ascending aortic diameter > 45mm or aiming to achieve t Receives: Device: Internal HAART 200 annuloplasty device |
| EXTERNAL group | Active comparator | For the EXTERNAL group, all study patients will undergo double external Dacron ring annuloplasty by simultaneous stabilization of the basal virtual ring and the STJ [22]. The surgical technique of double external annuloplasty, detailed by the Lansac group [22], involves aortic annulus sizing with a Hegar dilator to select the sizes of the external subannular annuloplasty ring and STJ ring (same size). After deep dissection of the aortic root, 6-7 2-0 pledgeted U sutures are placed circumferentially at the level of the virtual basal ring for external subannular ring implantation. Cusp maneuvers are performed similar to those in the INTERNAL group. STJ stabilization is achieved using an external STJ ring or ascending aortic replacement with a vascular tube graft (e.g., in cases with a high offspring of the right coronary artery). Treatment of the tubular ascending aorta is identical to the INTERNAL group. Receives: Device: double external ring annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-repair reduction of flow eccentricity in percent assessed via cardiac magnetic resonance imaging (MRI)
Flow eccentricity (in percent) will be assessed using cardiac with phase-contrast imaging. Flow eccentricity is calculated based on the deviation of the flow jet from the center of the vessel lumen. Measurements will be performed pre- and post-repair to determine the percentage reduction in flow eccentricity. Measurements will be performed pre- and post-repair to determine the percentage reduction in flow eccentricity.
Measured: Between the preoperative baseline (max. 30 days preoperative) (t1) and postoperative (pre-discharge) (t2) periods
Regurgitation fraction in percent assessed via cardiac magnetic resonance imaging (CMR)
The regurgitation fraction (%) will be assessed using cardiac magnetic resonance imaging (CMR) with phase-contrast imaging. Regurgitation fraction is calculated as the percentage of retrograde blood flow relative to the total blood flow through the valve. Measurements will be performed at baseline (pre-repair) and after the intervention (post-repair) to evaluate changes in regurgitation fraction.
For the second primary endpoint (regurgitation fraction), the dependent variable is the post (t2 and t3) value. The study group, time post-surgery (t2 and t3), the interaction between the study group and time post-surgery measurement, and center are included as independent fixed-effect variables.
Measured: Measurements will be taken at baseline (t1), an early post-operative time point (t2), and at 1-year follow-up (t3). The primary analysis will assess changes from baseline (t1) to both post-operative time points (t2 and t3).
Secondary outcomes (10)
Severity of aortic regurgitation (mild/moderate/severe)*
Severity will be assessed at months 6 (t2) and 12 (t3) in both study groups. The assessment is based on clinical imaging data, including transthoracic echocardiography (TTE) and cardiac MRI as available.
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Transvalvular gradient (mmHg)
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
All-cause mortality (yes/no)
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Adverse cardiac events (MACCE) (yes/no)
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Aortic valve re-intervention (yes/no)
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Re-hospitalization due to cardiac reasons (yes/no)
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Device-related complications (safety endpoint) (yes/no)
Measured: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Assessment of valvular cardiomyopathy: LV diameters (LVESD, LVEDD)
Left ventricular end-systolic diameter (LVESD) and left ventricular end-diastolic diameter (LVEDD) measured by echocardiography and/or cardiac MRI.
Measured: Assessment at post-procedural baseline (Day 0 = t1), month 6 (t2), and month 12 (t3) in both study groups.
Assessment of valvular cardiomyopathy LV volumes (LVESV, LVEDV)
Left ventricular end-systolic volume (LVESV) and left ventricular end-diastolic volume (LVEDV) measured by echocardiography and/or cardiac MRI.
Measured: Assessment at post-procedural baseline (t1), month 6 (t2), and month 12 (t3) in both study groups.
Assessment of valvular cardiomyopathy LV strain (GLS)
Global longitudinal strain (GLS) of the left ventricle assessed by echocardiography and/or cardiac MRI.
Measured: Assessment at post-procedural baseline (t1), month 6 (t2), and month 12 (t3) in both study groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start21 May 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bicuspid Aortic Valve (BAV)Studies 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
- Model description
- CONTOUR is a prospective, randomized, parallel, two-arm, and assessor-blinded multicenter trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Clinic Frankfurt, Heart Center Leipzig - University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869954
- Sponsor's protocol ID
- 23-0625
- Acronym
- CONTOUR
- Status last verified
- Oct 2025
- First submitted
- 22 Jan 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Girdauskas E, Stock S, Hofbauer D, Petersen J, Reichenspurner H, Holubec T, Walther T, Vogl T, Borger M, Gutberlet M, Kroncke T, Decker J, Zapf A, Lezius S, Lenz A, Lansac E, Bannas P. Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of the CONTOUR Trial. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf360. doi: 10.1093/ejcts/ezaf360.
PubMed 41124604
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial
- ClinicalTrials.gov ID
- NCT06869954
- Acronym / sponsor ID
- CONTOUR / 23-0625
- Keywords
- aortic regurgitation, aortic valve repair, annuloplasty, bicuspid aortic valve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Clinic Frankfurt, Heart Center Leipzig - University Hospital
- Study start
- 21 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Mar 2025 (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.
Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. The lack of sufficient standardization remains the main limitation of current repair techniques, resulting in an increased risk of AR recurrence and reoperation. The most controversial issue is the stabilization of the BAV annulus. The CONTOUR trial aims to compare two different BAV annuloplasty concepts in a prospective randomized study.
Methods: CONTOUR is a multicenter, randomized controlled trial designed to enroll 100 consecutive BAV patients with AR across four sites in Germany. BAV AR patients with an asymmetric configuration and without concomitant root aneurysm will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (i.e., INTERNAL group) (n=50) or external annuloplasty (i.e., double external ring annuloplasty) in the EXTERNAL group (n=50). 4D flow MRI will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of hemodynamic profiles (i.e., flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary endpoints will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up.
Discussion: The CONTOUR trial is designed to test the hypothesis that an internal annuloplasty device, creating a completely symmetric post-repair BAV geometry, achieves superior aortic valve repair outcomes compared to external annuloplasty. If our hypothesis is confirmed, our study will significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- CONTOUR is a prospective, randomized, parallel, two-arm, and assessor-blinded multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| INTERNAL Group | Active comparator | Device: Internal HAART 200 annuloplasty deviceFor the INTERNAL group, the HAART 200 internal annuloplasty ring (CorCym, London, UK), specifically designed for BAV morphology, will be used for all patients. Intraoperative sizing for the internal ring is based on the geometric orientation and size of the non-fused cusp. A standard ball sizer is used for the measurement of the non-fused cusp to assess commissural orientation and surface area of the non-fused cusp. Sizing typically results in values of 23mm or 25mm, with other sizes being very rare. Both commissural posts of the internal annuloplasty ring are fixed using two subcommissural sutures [10]. A modified technique for placement of transannular looping sutures will be used to secure the internal ring in the subannular position, as recently published [21]. Cusp maneuvers (i.e., shaving, thinning of the raphe, central plication sutures) will be performed to achieve an effective height of 8-10 mm. When indicated (i.e., for ascending aortic diameter > 45mm or aiming to achieve t |
| EXTERNAL group | Active comparator | Device: double external ring annuloplastyFor the EXTERNAL group, all study patients will undergo double external Dacron ring annuloplasty by simultaneous stabilization of the basal virtual ring and the STJ [22]. The surgical technique of double external annuloplasty, detailed by the Lansac group [22], involves aortic annulus sizing with a Hegar dilator to select the sizes of the external subannular annuloplasty ring and STJ ring (same size). After deep dissection of the aortic root, 6-7 2-0 pledgeted U sutures are placed circumferentially at the level of the virtual basal ring for external subannular ring implantation. Cusp maneuvers are performed similar to those in the INTERNAL group. STJ stabilization is achieved using an external STJ ring or ascending aortic replacement with a vascular tube graft (e.g., in cases with a high offspring of the right coronary artery). Treatment of the tubular ascending aorta is identical to the INTERNAL group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation < 170 degree) [14]
- Severe aortic regurgitation (vena contracta (vc) > 6mm and/or pressure half-time (PHT) < 200 ms and/or effective regurgitant orifice area (EROA) > 30 mm2 and/or regurgitant volume (RV) > 60 ml/beat and/or left ventricular end-systolic diameter (LVESD) > 50mm (or indexed LVESD > 20mm/m2 BSA) and/or regurgitation fraction (RF) in cardiothoracic MRI > 40%) (at least one parameter is required) [15]
- Isolated aortic valve surgery or concomitant procedure (including CABG and/or mitral/tricuspid valve surgery and/or ascending aortic surgery)
- Willingness to participate and written informed consent
- Age at surgery > 18 years
Key exclusion criteria (5 listed)
- Moderate/severe BAV stenosis (pmean > 20mmHg)
- Moderate/severe BAV cusp calcifications extending beyond the raphe region and/or necessitating patch implantation (deemed irreparable based on preoperative TOE (as by decision of the operating surgeon)
- Concomitant aortic root aneurysm > 45mm requiring simultaneous aortic root surgery [16]
- Acute/subacute BAV endocarditis
- Contraindication to MRI
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 |
|---|---|---|
| Internal HAART 200 annuloplasty deviceFor the INTERNAL group, the HAART 200 internal annuloplasty ring (CorCym, London, UK), specifically designed for BAV morphology, will be used for all patients. Intraoperative sizing for the internal ring is based on the geometric orientation and size of the non-fused cusp. A standard ball sizer is used for the measurement of the non-fused cusp to assess commissural orientation and surface area of the non-fused cusp. Sizing typically results in values of 23mm or 25mm, with other sizes being very rare. Both commissural posts of the internal annuloplasty ring are fixed using two subcommissural sutures [10]. A modified technique for placement of transannular looping sutures will be used to secure the internal ring in the subannular position, as recently published [21]. Cusp maneuvers (i.e., shaving, thinning of the raphe, central plication sutures) will be performed to achieve an effective height of 8-10 mm. When indicated (i.e., for ascending aortic diameter > 45mm or aiming to achieve th | Device | INTERNAL Group |
| double external ring annuloplastyFor the EXTERNAL group, all study patients will undergo double external Dacron ring annuloplasty by simultaneous stabilization of the basal virtual ring and the STJ [22]. The surgical technique of double external annuloplasty, detailed by the Lansac group [22], involves aortic annulus sizing with a Hegar dilator to select the sizes of the external subannular annuloplasty ring and STJ ring (same size). After deep dissection of the aortic root, 6-7 2-0 pledgeted U sutures are placed circumferentially at the level of the virtual basal ring for external subannular ring implantation. Cusp maneuvers are performed similar to those in the INTERNAL group. STJ stabilization is achieved using an external STJ ring or ascending aortic replacement with a vascular tube graft (e.g., in cases with a high offspring of the right coronary artery). Treatment of the tubular ascending aorta is identical to the INTERNAL group. | Device | EXTERNAL group |
Primary outcome
Post-repair reduction of flow eccentricity in percent assessed via cardiac magnetic resonance imaging (MRI)
Time frame: Between the preoperative baseline (max. 30 days preoperative) (t1) and postoperative (pre-discharge) (t2) periods
Flow eccentricity (in percent) will be assessed using cardiac with phase-contrast imaging. Flow eccentricity is calculated based on the deviation of the flow jet from the center of the vessel lumen. Measurements will be performed pre- and post-repair to determine the percentage reduction in flow eccentricity. Measurements will be performed pre- and post-repair to determine the percentage reduction in flow eccentricity.
Regurgitation fraction in percent assessed via cardiac magnetic resonance imaging (CMR)
Time frame: Measurements will be taken at baseline (t1), an early post-operative time point (t2), and at 1-year follow-up (t3). The primary analysis will assess changes from baseline (t1) to both post-operative time points (t2 and t3).
The regurgitation fraction (%) will be assessed using cardiac magnetic resonance imaging (CMR) with phase-contrast imaging. Regurgitation fraction is calculated as the percentage of retrograde blood flow relative to the total blood flow through the valve. Measurements will be performed at baseline (pre-repair) and after the intervention (post-repair) to evaluate changes in regurgitation fraction. For the second primary endpoint (regurgitation fraction), the dependent variable is the post (t2 and t3) value. The study group, time post-surgery (t2 and t3), the interaction between the study group and time post-surgery measurement, and center are included as independent fixed-effect variables.
10 secondary outcomes
Severity of aortic regurgitation (mild/moderate/severe)*
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Transvalvular gradient (mmHg)
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
All-cause mortality (yes/no)
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Adverse cardiac events (MACCE) (yes/no)
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Aortic valve re-intervention (yes/no)
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Re-hospitalization due to cardiac reasons (yes/no)
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Device-related complications (safety endpoint) (yes/no)
Time frame: Assessment at month 6 (t2) and month 12 (t3) in both study groups
Assessment of valvular cardiomyopathy: LV diameters (LVESD, LVEDD)
Time frame: Assessment at post-procedural baseline (Day 0 = t1), month 6 (t2), and month 12 (t3) in both study groups.
Assessment of valvular cardiomyopathy LV volumes (LVESV, LVEDV)
Time frame: Assessment at post-procedural baseline (t1), month 6 (t2), and month 12 (t3) in both study groups.
Assessment of valvular cardiomyopathy LV strain (GLS)
Time frame: Assessment at post-procedural baseline (t1), month 6 (t2), and month 12 (t3) in both study groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 41124604Girdauskas E, Stock S, Hofbauer D, Petersen J, Reichenspurner H, Holubec T, Walther T, Vogl T, Borger M, Gutberlet M, Kroncke T, Decker J, Zapf A, Lezius S, Lenz A, Lansac E, Bannas P. Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of the CONTOUR Trial. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf360. doi: 10.1093/ejcts/ezaf360.
- Individual participant dataSharing planned: No
Related trials for Bicuspid Aortic Valve (BAV)
RecruitingObservational study
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
RecruitingObservational study
Cardiovascular Health Improvement Project
Aortic Aneurysm, Aortic Dissection
Enrolling by invitation
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
RecruitingObservational study
A Study of Chinese Congenital Bicuspid Aortic Valve
Bicuspid Aortic Valve (BAV)
RecruitingObservational study
Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Bicuspid Aortic Valve (BAV)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal HAART 200 annuloplasty device and double external ring annuloplasty in people with Bicuspid Aortic Valve (BAV) and Aortic Regurgitation Disease, run by University Hospital Augsburg 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evaldas Girdauskas, Prof. (+49 821 4002671, evaldas.girdauskas@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-repair reduction of flow eccentricity in percent assessed via cardiac magnetic resonance imaging (MRI) (time frame: Between the preoperative baseline (max. 30 days preoperative) (t1) and postoperative (pre-discharge) (t2) periods). The study lists 2 primary outcomes in all. 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 NCT06869954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.