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New treatment option for Aortic Valve Stenosis
Official title MRI in Transcatheter Aortic Valve Replacement Patients
ClinicalTrials.gov ID: NCT05603026
What this study is testing
- What it's testing
- The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters.
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 105
You may be able to join if
- Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
- Planned transfemoral TAVR; 18 years of age or older;
- Able to give informed consent.
You likely can't join if
- Patients with permanent pacemakers or implantable defibrillators;
- Patients with non-MRI safe implants;
- Severe claustrophobia;
- Inability or contraindication to perform exercise bike stress test;
- Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
- Reduced left ventricular systolic function (\<40%);
See the full eligibility criteria
- Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
- Planned transfemoral TAVR; 18 years of age or older;
- Able to give informed consent.
- Patients with permanent pacemakers or implantable defibrillators;
- Patients with non-MRI safe implants;
- Severe claustrophobia;
- Inability or contraindication to perform exercise bike stress test;
- Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
- Reduced left ventricular systolic function (\<40%);
- History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
- Significant non-treated coronary artery disease.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
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 105 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. 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.