Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Apr 7, 2017

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments for patients with severe aortic valve stenosis, a condition where the heart's aortic valve narrows and makes it harder for blood to flow. The trial is looking to see if a procedure called Transcatheter Aortic Valve Implantation (TAVI), which is less invasive, is just as safe and effective as the traditional surgical option known as Surgical Aortic Valve Replacement (SAVR). Patients in this study will be randomly assigned to receive either TAVI or SAVR, and researchers will track their health outcomes, including overall survival and the occurrence of strokes, over a period of one and five years.

To be eligible for this trial, patients generally need to be between the ages of 65 and 85, have symptoms from their aortic valve disease, and be classified as having low to intermediate risk for surgery. This means their overall health and medical conditions make them suitable for either treatment option. Participants will need to agree to follow-up visits after the procedure, and they will provide informed consent to take part in the study. It’s important to note that certain health issues or prior medical histories may prevent someone from joining the trial, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Heart team consensus that TAVI and SAVR are both medically justified and advisable based on:
• 1. Degenerative aortic valve stenosis with echocardiographically derived criteria:
• • Mean gradient \>40 mmHg or
• • Jet velocity greater than 4.0 m/s or
• • Aortic valve area (AVA) of \< 1.0 cm2 (indexed effective orifice area \< 0.6cm2/m2).
• • 2. Patient is symptomatic from his/her aortic valve stenosis
• • New York Heart Association Functional Class ≥ II or
• • Angina pectoris or
• • Syncope.
• • 3. Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE).
• • 4. A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus.
• • 2. Patient has provided written informed consent to participate in the trial.
• • 3. Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures.
• • 4. The patient agrees to undergo SAVR, if randomized to control treatment.
• • 5. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
• • 6. Patients aged 65 to 85 years.
• • 7. Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause.
• Exclusion Criteria:
• • 1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
• • 2. Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus
• • 3. Previous cardiac surgery
• • 4. Any percutaneous coronary intervention performed within 1 month prior to the study procedure
• • 5. Untreated severe mitral or tricuspid regurgitation
• • 6. Untreated severe mitral stenosis
• • 7. Hemodynamic instability requiring inotropic support or mechanical circulatory support
• • 8. Ischemic stroke or intracranial bleeding within 1 month
• • 9. Severe ventricular dysfunction with left ventricular ejection fraction \< 20% as measured by resting echocardiogram
• • 10. Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient
• • 11. Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis
• • 12. Any other condition considered a contraindication for an isolated aortic valve procedure
• • 13. Symptomatic carotid or vertebral artery disease
• • 14. Expected life expectancy \< 12 months due to associated non-cardiac comorbidities
• • 15. Currently participating in another investigational drug or device trial