Comparing two ways to stabilize the bicuspid aortic valve during repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CONTOUR is a multicenter, randomized trial in Germany enrolling 100 adults with fused, asymmetric bicuspid aortic valves and severe aortic regurgitation to compare two annuloplasty concepts. Eligible patients without a concomitant root aneurysm are randomized 1:1 to receive either an internal HAART 200 annuloplasty device or a double external ring annuloplasty at the time of aortic valve repair. The trial will collect surgical, echocardiographic, and clinical outcomes to compare annular stabilization, recurrence of regurgitation, and need for reoperation. Participating centers include University Hospital Augsburg, Universitätsklinikum Hamburg-Eppendorf, University Heart and Vascular Center Frankfurt, and Heart Center Leipzig.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation \< 170 degree) \[14\]
2. 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) \[15\]
3. Isolated aortic valve surgery or concomitant procedure (including CABG and/or mitral/tricuspid valve surgery and/or ascending aortic surgery)
4. Willingness to participate and written informed consent
5. Age at surgery \> 18 years

Exclusion Criteria:

1. Moderate/severe BAV stenosis (pmean \> 20mmHg)
2. 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)
3. Concomitant aortic root aneurysm \> 45mm requiring simultaneous aortic root surgery \[16\]
4. Acute/subacute BAV endocarditis
5. Contraindication to MRI

Where it's running

• University Hospital Augsburg
  Augsburg, Bavaria, Germany Recruiting
• Medical Center Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• University Heart and Vascular Center Frankfurt
  Frankfurt am Main, Hesse, Germany Not yet recruiting
• Heart Center Leipzig
  Leipzig, Saxony, Germany Not yet recruiting

Study contacts

• Study coordinator: Evaldas Girdauskas, Prof.
• Email: evaldas.girdauskas@uk-augsburg.de
• Phone: +49 821 4002671

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aspirin by itself after TAVR for pure aortic regurgitation

  In people with severe aortic regurgitation who have had TAVR and do not need long-term anticoagulation, this study tests whether aspirin alone for a year is safer and as effective as a short course of warfarin followed by aspirin.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07677410

• AI tool to detect and measure aortic regurgitation

  This project will test an AI-assisted echocardiography tool to detect and measure aortic regurgitation in adults and compare its results with standard manual measurements.

  Recruiting Chinese University of Hong Kong · Hong Kong, New Territories · NCT07486271

• Finger photoacoustic arterial waveform monitoring for aortic valve disease and healthy adults

  This project will test whether a finger-based photoacoustic device can capture arterial pulse waveforms and help identify aortic stenosis, aortic regurgitation, or normal heart function in adults.

  Recruiting Anhui Provincial Cancer Hospital · Hefei, Anhui · NCT07350629

• Losartan after aortic valve replacement to help the heart recover

  This trial will try if taking losartan after aortic valve replacement helps the heart shrink back to a healthier size and improve recovery in adults who had severe aortic regurgitation.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07099859

• ARTEMIS: JenaValve Trilogy data collection for severe aortic regurgitation

  This project will try the JenaValve Trilogy transcatheter heart valve in adults with severe native aortic regurgitation who are high or prohibitive risk for open-heart surgery.

  Recruiting IRCCS Policlinico S. Donato · San Donato Milanese, Milano · NCT07075861

• Assessing how anesthesia and imaging affect aortic regurgitation evaluation

  This study is testing how different types of heart imaging before and after anesthesia affect the way doctors measure aortic regurgitation in patients getting heart surgery.

  Recruiting University of Liege · Liège · NCT06835946

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.