BridgeMD
New treatment option for Severe Aortic Valve Disease
Official title Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargement
ClinicalTrials.gov ID: NCT07368322
What this study is testing
- What it's testing
- Abstract Background: Aortic valve replacement (AVR) is crucial for patients with severe aortic valve disease. However, managing those with a small aortic annulus (SAA, i.e., annulus diameter \< 22 mm) is challenging because implanting a small prosthesis can result in patient-prosthesis mismatch (PPM), suboptimal hemodynamic outcomes, and reduced long-term survival.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Adults aged 18-80 years.
- Patients must have signed and dated an ICF in accordance with regulatory and institutional guidelines before any protocol-related procedures and must...
- Diagnosed with aortic valve disease requiring aortic valve replacement.
- Patients with small aortic annulus relative to body size where conventional AVR result in moderate or severe PPM (defined as cases where the largest...
- Suitable candidates for surgery as determined by the heart team.
You likely can't join if
- Patients for whom conventional AVR without root enlargement is not expected to result in patient-prosthesis mismatch.
- Prior cardiac surgery.
- Severe concomitant valvular disease requiring additional procedures.
- Active endocarditis.
- Severe chronic lung disease
- Pre-existing lower limb deficits or any other medical comorbidities that interfere significantly with gait or the ability to perform exercise testing...
See the full eligibility criteria
- Adults aged 18-80 years.
- Patients must have signed and dated an ICF in accordance with regulatory and institutional guidelines before any protocol-related procedures and must be willing and able to comply with scheduled visits.
- Diagnosed with aortic valve disease requiring aortic valve replacement.
- Patients with small aortic annulus relative to body size where conventional AVR result in moderate or severe PPM (defined as cases where the largest prosthesis that can be implanted in the native annulus would provide a...
- Suitable candidates for surgery as determined by the heart team.
- Patients for whom conventional AVR without root enlargement is not expected to result in patient-prosthesis mismatch.
- Prior cardiac surgery.
- Severe concomitant valvular disease requiring additional procedures.
- Active endocarditis.
- Severe chronic lung disease
- Pre-existing lower limb deficits or any other medical comorbidities that interfere significantly with gait or the ability to perform exercise testing on a bicycle ergometer
- Severe left ventricular dysfunction (LVEF \< 30%).
- Contraindications to surgery.
- Concurrent active treatment in another clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Haifa, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haifa, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.