Study: Small Annuli Randomized to Evolut™ or SAPIEN™
Zusammenfassung der Studie
The aortic valve of a heart can narrow due to deposits (e.g., calcium, etc.) (aortic stenosis), making it difficult for blood to flow from the heart. An intervention to replace the diseased aortic valve is the standard treatment for aortic stenosis. This can be performed, among other methods, through a transcatheter aortic valve replacement (TAVR). In such an intervention, a flexible tube (catheter) containing the artificial heart valve is inserted through an incision in the skin at the groin and pushed through a blood vessel to the heart. No open-heart surgery is required. Patients for whom a TAVR is to be performed due to their aortic stenosis may participate in this study under certain conditions. If a patient is eligible for participation, they will receive either a commercially available self-expanding (SE) TAV from Medtronic or a balloon-expandable (BE) TAV from Edwards. The patient will be assigned to one of the two study groups (randomized). One group receives the self-expanding (SE) TAV from Medtronic and the other the balloon-expandable (BE) TAV from Edwards. Randomization means that a computer randomly assigns the patient to a group. Neither the patient nor the doctors can decide which group the patient will be in. For this study, data/information from the treatment routine will be collected. Additionally, electrocardiograms (recording of the electrical activities of the heart muscle fibers) and transthoracic echocardiograms (examination of the heart using a transducer placed on the chest) may be performed, and questionnaires may be administered that do not conform to the treatment routine but do not impose any additional burden on the patient.
(BASEC)
Untersuchte Intervention
The purpose of this study is to obtain clinical insights into the valve safety and performance of the balloon-expandable (BE) compared to a self-expanding (SE) transcatheter aortic valve replacement (TAVR) in patients with a small aortic annulus and symptomatic severe native aortic stenosis.
Approximately 700 treated study participants at about 90 study centers in Canada, the European Economic Area, the Middle East, Africa, and the United States are expected to participate in the study.
Data from study patients will be collected at the following time points:
- Screening
- Baseline
- TAVR procedure
- Discharge
- 30 days and annually up to 5 years after the procedure
Data will primarily come from routine treatment. Additionally, electrocardiograms (recording of the electrical activities of the heart muscle fibers) and transthoracic echocardiograms (examination of the heart using a transducer placed on the chest) may be performed, and questionnaires may be administered that do not conform to the treatment routine but do not impose any additional burden on the patient.
(BASEC)
Untersuchte Krankheit(en)
Patients with symptomatic heart disease due to severe native calcific aortic stenosis and a small annulus suitable for transcatheter heart valve replacement therapy. The products used in this study are CE marked and approved for public use in patients with aortic stenosis. The products are used according to the authorization in Switzerland. Product names - Medtronic Evolut™ PRO, Evolut™ PRO+ and Evolut™ FX* transcatheter aortic valve systems (TAV systems, Transcatheter Aortic Valve) - Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems (THV systems, Transcatheter Heart Valve) * Note: The Evolut™ FX system is commercially available in the United States. The Evolut™ FX system may be used when commercially available in Canada.
(BASEC)
1. The patient's estimated operative mortality risk as assessed by the local cardiology team is <15% at 30 days. 2. The patient has been diagnosed with severe aortic stenosis. 3. The area of the patient's aortic valve annulus is ≤430 mm2. 4. The patient is suitable for treatment with both Medtronic Evolut TAV and Edwards TAV systems used within the conduct of the trial. 5. The patient is suitable for TAVR via vascular access through the femoral artery. 6. The patient and the treating physician agree that the patient will return to the study center for all required follow-up appointments after the procedure. (BASEC)
Ausschlusskriterien
1. The patient's estimated life expectancy is less than 2 years. 2. The patient has multiple narrowed coronary vessels and/or the patient has an unprotected left main coronary artery. 3. The patient is participating in another study that could influence the outcome of this study. 4. The patient requires an emergency intervention for any reason. 5. Treatment with Medtronic Evolut and Edwards TAV systems according to the instructions for use cannot be performed on the patient. 6. Other medical, social, or psychological circumstances that, in the investigator's discretion, exclude the patient from providing appropriate informed consent or from complying with the follow-up examinations required by the protocol. 7. The patient is pregnant, breastfeeding, or planning a pregnancy. 8. The patient is a minor, legally incompetent, unable to provide informed consent, or otherwise vulnerable. 9. The patient has an active COVID-19 infection or relevant history of COVID-19. 10. The patient has previously received an aortic valve replacement. (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Medtronic (Schweiz) AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Thomas Pilgrim
031 632 50 00
kardio.studien@clutterinsel.chInsel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie
(BASEC)
Allgemeine Auskünfte
University of Pennsylvania, United States,Mount Sinai School of Medicine, United States,Clinique Pasteur Toulouse, France
(ICTRP)
Allgemeine Auskünfte
University of Pennsylvania, United StatesMount Sinai School of Medicine, United StatesClinique Pasteur Toulouse, France
(ICTRP)
Wissenschaftliche Auskünfte
University of Pennsylvania, United States,Mount Sinai School of Medicine, United States,Clinique Pasteur Toulouse, France
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.11.2021
(BASEC)
ICTRP Studien-ID
NCT04722250 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Small Annuli Randomized To Evolut™ or SAPIENTM Trial (SMART Trial) (BASEC)
Wissenschaftlicher Titel
SMall Annuli Randomized To Evolut or SAPIEN Trial (ICTRP)
Öffentlicher Titel
SMall Annuli Randomized To Evolut or SAPIEN Trial (ICTRP)
Untersuchte Krankheit(en)
Symptomatic Aortic StenosisAortic Valve StenosisAortic Valve Replacement (ICTRP)
Untersuchte Intervention
Device: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV SystemsDevice: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Heart Team agrees that the subject is deemed symptomatic and is a candidate for
transcatheter aortic valve replacement (TAVR)
- Subject has a predicted risk of operative mortality < 15% as determined by the local
Heart Team
- Subject has severe aortic stenosis as determined by transthoracic echocardiography
(TTE) at rest
- Subject has a small aortic annulus as determined by Multi-detector computed
tomography (MDCT)
- Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and
Edwards SAPIEN 3/3 Ultra TAV
- Subject's anatomy is suitable for TAVR via transfemoral vessel access
- Subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits
Exclusion Criteria:
- Estimated life expectancy of fewer than 2 years
- Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left
main coronary artery(Syntax score calculation is not required for patients with
history of previous revascularization if repeat revascularization is not planned).
- Participating in another trial that may influence the outcome of this trial
- Need for an emergent procedure for any reason
- Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3
Ultra TAV in accordance with the Instructions for Use
- Other medical, social, or psychological conditions that in the opinion of the
Investigator precludes the subject from appropriate consent or adherence to the
protocol required follow-up exams
- Pregnant, nursing, or planning to be pregnant
- Subject is less than the legal age of consent, legally incompetent, unable to
provide his/her own informed consent, or otherwise vulnerable
- Subject has an active COVID-19 infection or relevant history of COVID-19
- Previous aortic valve replacement (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Mortality, Disabling Stroke or Heart Failure Rehospitalization;Bioprosthetic Valve Dysfunction (BVD) (ICTRP)
Percentage of Participants With BVD in Female Subjects;Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD);Hemodynamic Mean Gradient as Continuous Variable;Effective Orifice Area (EOA) as a Continuous Variable;Rate of Moderate or Severe Prothesis-patient Mismatch (PPM) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Howard Herrmann, MD;Roxana Mehran, MD;Didier Tch?tch?, MD, University of Pennsylvania, United States,Mount Sinai School of Medicine, United States,Clinique Pasteur Toulouse, France (ICTRP)
Sekundäre IDs
MDT20023EVR012 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04722250 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar