Join The Trial
To achieve the required number of enrolled patients, we are looking for organizations and individuals to join the trial:
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If you or a person you know is suffering from a worn-out aortic bioprosthesis and meets the inclusion criteria, please contact us below.
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If you are working for a health-care institution with an established Heart Team and would like to enroll patients, please contact us below.
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If you work for a non-profit organization or would like to individually sponsor the trial, please contact us.
Inclusion Criteria
In order to be eligible for the trial, you will need to meet the following criteria:
Only patients younger than 75 years of age are allowed to enter the trial.
Be up to 75 years of age
1
Patients must have undergone prior open heart surgery for a diseased aortic valve. During this operation, a bioprosthetic heart valve was implanted. This valve is now worn out, requiring treatment.
Have a failed surgical aortic bioprosthesis
2
Doctors evaluate the patient as not being at high-risk for repeat open heart surgery.
Be of lower Surgical Risk
3
Exclusion Criteria
We are unable to accept any of the following criteria:
If there are signs of valve infection, patients cannot enter the trial.
Valve Infection
1
If further interventions such as bypass surgery or valve treatments other than the worn-out bioprostheses are required, patients are excluded from the trial.
Further Interventions
2
If a mechanical valve has been implanted during the initial open heart surgery, or a patient wants to receive a mechanical heart valve now, it is not possible to participate in the trial.
Mechanical Valves
3
Study Protocol
Patients presenting with a surgical aortic bioprosthesis requiring treatment due to valve failure are evaluated by a team of experts at the respective hospital, a so-called Heart Team, including cardiologists, cardiac surgeons, anesthesiologists, and radiologists. If this Heart Team evaluates the patient as eligible for being randomized to either treatment, doctors are going to obtain consent from the individual.
Patients who are entering the trial are treated based on standard of care protocols during the hospital stay. In addition, health-related information is gathered prior to the intervention using questionnaires, and a 6-Minutes walk test is performed. Prior to discharge, a cardiac ultrasound is conducted, which is common practice in most heart centers.
Each patient is followed up annually, for a total of 5 years following the intervention. These follow-up visits are in person at year 1, 3, and 5, while phone-call follow-ups are conducted at year 2 and 4. The in-person follow-up visits include a cardiac ultrasound and quality of life questionnaires, and can be done at the center where the intervention has been performed, or at a hospital closer to where the patient is living.
If you would like to learn more or contact us regarding the trial, please email or contact us.
Please get in touch with us
We would like to hear from potentially participating sites, patients or their family members, scientists, physicians, or sponsors.