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New treatment option for Aortic Valve Stenosis
Official title Impact of Beta Blockers on TAVI (BETA-TAVI)
ClinicalTrials.gov ID: NCT05721170
What this study is testing
What is Beta blocker?
Beta blocker is an investigational medicine, being studied as a potential treatment for aortic valve stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI.
- Phase 4: studies an already-approved treatment
- 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 and older
You may be able to join if
- Study population Eligible patients are adults that whom TAVI is indicated as therapy for severe aortic valve stenosis and will be assigned randomly...
- Adults ≥18 years old.
- Patient with severe symptomatic aortic stenosis defined by mean aortic gradient \> 40 mmHg or/and peak jet velocity \> 4.0 m/s or/and aortic valve...
- Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of at...
- Patients with anatomic characteristics suitable for TAVI based on the local Heart Team decision.
You likely can't join if
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, bivalirudin...
- Patients with permanent pacemaker or defibrillator.
- Ongoing infection, including active endocarditis.
- Echocardiographic evidence of LV or LA thrombus.
- The patient that has any contraindication for antithrombotic treatment.
- Estimated life expectancy of less than 12 months.
See the full eligibility criteria
- Study population Eligible patients are adults that whom TAVI is indicated as therapy for severe aortic valve stenosis and will be assigned randomly in a 1:1 ratio to either continue or withdraw the beta-blockers...
- Adults ≥18 years old.
- Patient with severe symptomatic aortic stenosis defined by mean aortic gradient \> 40 mmHg or/and peak jet velocity \> 4.0 m/s or/and aortic valve area (AVA) \< 1cm2 or/and AVA indexed to body surface area (BSA) of...
- Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of at least a cardiologist and surgeon.
- Patients with anatomic characteristics suitable for TAVI based on the local Heart Team decision.
- Patients receiving beta-blockers as a part of their indicated treatment plan.
- Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
- Patient has given written consent to participate in the trial.
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, bivalirudin, clopidogrel, titanium, nickel, cobaltium, chromium, contrast media.
- Patients with permanent pacemaker or defibrillator.
- Ongoing infection, including active endocarditis.
- Echocardiographic evidence of LV or LA thrombus.
- The patient that has any contraindication for antithrombotic treatment.
- Estimated life expectancy of less than 12 months.
- Pregnancy and pre-perimenopause.
- 2nd and 3rd degree atrioventricular (AV) block.
- Bradycardia (\<50 beats per minute) at the electrocardiogram (ECG) on the screening/baseline visit.
- Co-morbidity that excludes or significantly interferes with the follow-up visits.
- Enrolment in another study that competes or interferes with this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nicosia, Cyprus
- Athens, Attica, Greece
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nicosia, Cyprus; Athens, Attica, Greece. 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.