Aortic RegurgitationMARVELTAVINCT07751965
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
A study testing Myval THV series in people with Aortic Regurgitation and Aortic Disease, run by Ceric Sàrl.
Trial summary
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- What is being tested?
- Myval THV series
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Mar 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient above 18 years of age.
- Patients must have co-morbidities such that the heart team and Investigator concur that the predicted risk of operative mortality is high.
- Patient has non- or mild-calcified aortic regurgitation, undergoing TAVI with Myval THV Series without any degree stenosis, and severe aortic regurgitation as per investigator/ Heart team discretion according to (at least one) imaging criteria that can include:
- Echocardiographically derived criteria: regurgitant volume ≥60 ml/beat, regurgitant fraction ≥50%, effective regurgitant orifice ≥0.3cm2, holodiastolic flow reversal at the level of the mid-descending aorta with an end diastolic flow velocity greater than 20 cm/s, width of vena contracta ≥6mm, hemi pressure time <200 msec, or vena contracta area assessed with 3D echo ≥0.4 cm².
- AND/OR
- Cardiac magnetic resonance derived criteria: Regurgitant fraction >40% or regurgitant volume >60mL.
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- Patient suitable for implantation with Myval THV series via transfemoral approach.
- Patient is symptomatic from his/her aortic valve regurgitation, as demonstrated by the New York Heart Association (NYHA) Functional Class ≥II.
- Patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee of the respective clinical site.
- The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
Who cannot join
- Patients who are not willing to provide informed consent form, or whose legal heirs object to participate in the study
- Pregnant and lactating female patients
- Evidence of an acute myocardial infarction ≤1 month before the intended treatment
- Mixed aortic valve disease
- Moderate-severe calcification of aortic valve
- Bicuspid aortic valve disease according to treating physician (if detected by the corelab it will not be excluded except if so considered by the steering committee)
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- Congenital unicuspid patients
- Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent/scaffold implantation).
- Pre-existing prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification (MAC), severe (greater than 3+) mitral insufficiency, or Gorlin syndrome.
- Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dl), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Need for emergency surgery other than aortic valve replacement with the study device.
- Hypertrophic cardiomyopathy with or without obstruction (HOCM).
- Very severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <15%.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper GI bleeding within the prior 3 months.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated.
- Recent (within 6 months) cerebrovascular accident (CVA) or a Transient Ischemic Attack (TIA).
- Renal insufficiency and/or end stage renal disease requiring chronic dialysis
- Life expectancy <1 year due to non-cardiac co-morbid conditions.
- Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only) which would make Transcatheter Aortic Valve Implantation (TAVI) unfeasible as per the Investigator/Heart Team.
- Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity or vessels with adequate femoral size (applicable for transfemoral patients only).
- Currently participating in an investigational drug or another device study which has not achieved the primary endpoint.
- Active bacterial endocarditis or other active infections.
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicenter, Single-arm, Open-label Study Evaluating the Safety and Effectiveness of the Myval Transcatheter Heart Valve (THV) System in High-risk Patients With Severe Symptomatic Non- or Mildly Calcified Aortic Regurgitation.
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
Read the detailed description
Severe symptomatic aortic regurgitation (AR) in high-risk or inoperable patients with non- or mildly calcified valves has limited treatment options. While TAVR has emerged as a viable approach in aortic stenosis, its use in aortic regurgitation remains limited due to anatomical complexities, the absence of dedicated devices, and the prevalence of large annular dimensions in these patients.Dedicated devices like the JenaValve Trilogy™ demonstrated safety and efficacy in trials such as ALIGN-AR and JUPITER registry, but use is restricted by annular size limitations.Additionally, The PANTHEON International Project demonstrated safety and efficacy of balloon and self-expandable valves in severe AR patients. Despite improved THV platforms and techniques, TAVR for pure native aortic valve regurgitation remains a challenging procedure, with significant risk for transcatheter valve embolization or migration (TVEM).The Myval THV series offers a broader size range from 20mm-35mm and allows for controlled oversizing, as demonstrated in a large international registry showing high technical success and favorable 1-year outcomes in patients with non-calcified AR.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Being tested
- Myval THV series
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Diseases, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myval THV seriesDevice
All patients with severe symptomatic non- or mild-calcified aortic regurgitation undergoing TAVR using Myval THV series in high surgical risk based on investigator/Heart team discretion who meet study eligibility criteria.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | All patients with severe symptomatic non- or mild-calcified aortic regurgitation undergoing TAVR using Myval THV series in high surgical risk based on investigator/Heart team discretion who meet study eligibility criteria. Receives: Device: Myval THV series |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Death due to any cause occurring during the specified follow-up period.
Measured: 30 days
All Stroke
Any ischemic or hemorrhagic stroke confirmed by clinical evaluation and/or appropriate imaging during follow-up.
Measured: 30 days
Bleeding (Type 3 & 4)
Major bleeding events classified as Bleeding Academic Research Consortium (BARC) Type 3 or Type 4.
Measured: 30 days
Major vascular complications
Major vascular access- or procedure-related complications as defined by the Valve Academic Research Consortium (VARC) criteria.
Measured: 30 days
Acute Kidney Injury (Stage 3 and 4)
Acute kidney injury meeting Stage 3 or Stage 4 severity according to the applicable VARC/AKI classification criteria.
Measured: 30 days
Surgery/Intervention related to device
Any unplanned surgical or catheter-based intervention performed to correct or treat a device-related complication.
Measured: 30 days
Conduction system disturbances resulting in a new permanent pacemaker implantation
New conduction abnormalities requiring implantation of a permanent pacemaker after the index procedure.
Measured: 30 days
Greater than or equal to Moderate Paravalvular Regurgitation
Presence of moderate or severe paravalvular regurgitation as determined by echocardiographic assessment during follow-up.
Measured: 30 days
Secondary outcomes (17)
All cause mortality
Death due to any cause occurring during the specified follow-up period.
Measured: 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
All Stroke
Any ischemic or hemorrhagic stroke confirmed by clinical evaluation and/or appropriate imaging during follow-up.
Measured: 1 years, 3 years and 5 years
Bleeding (Type 3 & 4)
Major bleeding events classified as Bleeding Academic Research Consortium (BARC) Type 3 or Type 4.
Measured: 1 year, 3 years and 5 years
Surgery/Intervention related to device
Any unplanned surgical or catheter-based intervention performed to correct or treat a device-related complication.
Measured: 1 year, 3 years and 5 years
Conduction system disturbances resulting in a new permanent pacemaker implantation
New conduction abnormalities requiring implantation of a permanent pacemaker after the index procedure and during follow up
Measured: 1 year, 3 years and 5 years
Re-hospitalization for procedure-related or valve-related causes
Any unplanned hospital admission due to complications related to the index procedure or the implanted valve during the follow-up period.
Measured: 30 days, 1 year, 3 years and 5 years
NYHA functional improvement
Improvement or change in New York Heart Association (NYHA) functional class from baseline during the follow-up period.
Measured: 30 days, 1 year, 3 years and 5 years
Residual aortic regurgitation ≤ mild
Presence of none/trace or mild residual aortic regurgitation as assessed by echocardiography during follow-up.
Measured: 30 days, 1 year, 3 years and 5 years
Six-minute walk test
Change in functional exercise capacity measured by the distance walked during the standardized six-minute walk test (6MWT).
Measured: 30 days, 1 year, 3 years and 5 years
Evidence of bioprosthetic valve dysfunction and bioprosthetic valve failure
Occurrence of bioprosthetic valve dysfunction or bioprosthetic valve failure as assessed according to established VARC-3 criteria during the follow-up period.
Measured: 1 year, 3 year and 5 year
Bioprosthetic valve deterioration
Occurrence of bioprosthetic valve deterioration, including structural valve deterioration, as assessed according to established VARC-3 criteria during the follow-up period.
Measured: 1 year
Length of index hospital stay
Number of days spent in hospital
Measured: From procedure up to discharge, assessed until 2-3 days post procedure
Improved KCCQ from baseline
This is a Quality of Life questionnaire which includes Kansas City Cardiomyopathy Questionnaire (KCCQ), where usually improvement from baseline is calculated , not simply the absolute score. Higher KCCQ score means better quality of life and Lower KCCQ score means lower quality of life
Measured: 30 days, 1 year, 3 years and 5 years
Improved EQ-5D from baseline
The EQ-5D (EuroQol 5-Dimension questionnaire) is another standard patient-reported outcome (PRO) used in TAVI studies. This is a generic health-related quality of life (HRQoL) instrument that allows comparisons across different diseases and is frequently used for health economic analyses. Similar to that KCCQ, here as well higher the score, better the quality of life and vice versa for lower score.
Measured: 30 days, 1 year, 3 years and 5 years
Improved valve function
Percentage of patients with none/trace, mild, or less aortic regurgitation on echocardiographic assessment during follow-up (responder analysis).
Measured: 30 days, 1 year, 3 years and 5 years
Technical success at exit from procedure
Successful implantation and function of the study device without procedural mortality, need for surgery or intervention related to the device, or device malfunction at exit from the procedure, as defined by VARC-3 criteria.
Measured: 30 days
Device Success
Successful implantation and intended performance of the study device without procedural mortality, as assessed according to VARC-3 criteria.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignacio Amat Santos, Principal investigator, Hospital Clínico UniversHospital Clínico Universitario de Valladolid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751965
- Sponsor's protocol ID
- MYV/MARVEL TAVI-1
- Acronym
- MARVELTAVI
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shelkey M, Wallace M. Katz Index of Independence in Activities of Daily Living (ADL). Director. 2000 Spring;8(2):72-3. No abstract available.
PubMed 11081028Corrigendum to: 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2022 Jun 1;43(21):2022. doi: 10.1093/eurheartj/ehac051. No abstract available.
PubMed 35188539ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180De Backer O, Pilgrim T, Simonato M, Mackensen GB, Fiorina C, Veulemanns V, Cerillo A, Schofer J, Amabile N, Achkouty G, Schafer U, Deutsch MA, Sinning JM, Rahman MS, Sawaya FJ, Hildick-Smith D, Hernandez JM, Kim WK, Lefevre T, Seiffert M, Bleiziffer S, Petronio AS, Van Mieghem N, Taramasso M, Sondergaard L, Windecker S, Latib A, Dvir D. Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation. Am J Cardiol. 2018 Sep 15;122(6):1028-1035. doi: 10.1016/j.amjcard.2018.05.044. Epub 2018 Jun 27.
PubMed 30072124Sawaya FJ, Deutsch MA, Seiffert M, Yoon SH, Codner P, Wickramarachchi U, Latib A, Petronio AS, Rodes-Cabau J, Taramasso M, Spaziano M, Bosmans J, Biasco L, Mylotte D, Savontaus M, Gheeraert P, Chan J, Jorgensen TH, Sievert H, Mocetti M, Lefevre T, Maisano F, Mangieri A, Hildick-Smith D, Kornowski R, Makkar R, Bleiziffer S, Sondergaard L, De Backer O. Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. JACC Cardiovasc Interv. 2017 May 22;10(10):1048-1056. doi: 10.1016/j.jcin.2017.03.004.
PubMed 28521923Yoon SH, Schmidt T, Bleiziffer S, Schofer N, Fiorina C, Munoz-Garcia AJ, Yzeiraj E, Amat-Santos IJ, Tchetche D, Jung C, Fujita B, Mangieri A, Deutsch MA, Ubben T, Deuschl F, Kuwata S, De Biase C, Williams T, Dhoble A, Kim WK, Ferrari E, Barbanti M, Vollema EM, Miceli A, Giannini C, Attizzani GF, Kong WKF, Gutierrez-Ibanes E, Jimenez Diaz VA, Wijeysundera HC, Kaneko H, Chakravarty T, Makar M, Sievert H, Hengstenberg C, Prendergast BD, Vincent F, Abdel-Wahab M, Nombela-Franco L, Silaschi M, Tarantini G, Butter C, Ensminger SM, Hildick-Smith D, Petronio AS, Yin WH, De Marco F, Testa L, Van Mieghem NM, Whisenant BK, Kuck KH, Colombo A, Kar S, Moris C, Delgado V, Maisano F, Nietlispach F, Mack MJ, Schofer J, Schaefer U, Bax JJ, Frerker C, Latib A, Makkar RR. Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. J Am Coll Cardiol. 2017 Dec 5;70(22):2752-2763. doi: 10.1016/j.jacc.2017.10.006.
PubMed 29191323Elkoumy A, Jose J, Gunasekaran S, Kumar A, Srinivas BC, Manjunath CN, Ravindranath KS, Parekh M, Chandra P, Kapoor R, Abdelshafy M, Seth A, Agrawal P, Mathur A, Rao RS, Elzomor H, Sadanada KS, Kumar V, Arsang-Jang S, Mehrotra S, Raghuraman B, Khanolkar U, Premchand RK, Chopra M, Krishna P, Mehta H, Gupta R, Kumar V, Senguttuvan NB, Baumbach A, Serruys PW, Soliman O. Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication. Int J Cardiol. 2023 Jul 1;382:68-75. doi: 10.1016/j.ijcard.2023.04.003. Epub 2023 Apr 5.
PubMed 37028710Poletti E, De Backer O, Scotti A, Costa G, Bruno F, Fiorina C, Buzzatti N, Latini A, Rudolph TK, van den Dorpel MMP, Brinkmann C, Patel KP, Panoulas V, Schofer J, Giordano A, Barbanti M, Regazzoli D, Taramasso M, Saia F, Baumbach A, Maisano F, Van Mieghem NM, Sondergaard L, Latib A, Amat Santos IJ, Bedogni F, Testa L. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv. 2023 Aug 28;16(16):1974-1985. doi: 10.1016/j.jcin.2023.07.026.
PubMed 37648345Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 2018 Jun;91(7):1345-1351. doi: 10.1002/ccd.27370. Epub 2017 Nov 24.
PubMed 29171730Rawasia WF, Khan MS, Usman MS, Siddiqi TJ, Mujeeb FA, Chundrigar M, Kalra A, Alkhouli M, Kavinsky CJ, Bhatt DL. Safety and efficacy of transcatheter aortic valve replacement for native aortic valve regurgitation: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):345-353. doi: 10.1002/ccd.27840. Epub 2018 Sep 30.
PubMed 30269437Markham R, Ghodsian M, Sharma R. TAVR in Patients with Pure Aortic Regurgitation: Ready to Use? Curr Cardiol Rep. 2020 Jul 28;22(9):98. doi: 10.1007/s11886-020-01338-6.
PubMed 32725310Siani A, Perone F, Costantini P, Rodolfi S, Muscogiuri G, Sironi S, Carriero S, Pavon AG, van der Bilt I, van Rosendael P, Broekhuizen L, Teske A, Cramer MJ, Guglielmo M. Aortic regurgitation: A multimodality approach. J Clin Ultrasound. 2022 Oct;50(8):1041-1050. doi: 10.1002/jcu.23299.
PubMed 36218214Makkar RR, Thourani VH, Vahl TP, Yadav PK, McCabe JM, George I, Satler L, Chetcuti S, Daniels DV, Waggoner T, Whisenant B, Russo M, Summers M, Garcia S, Frisoli T, Ramana RK, Stinis C, Golwala H, Zahr F, Greenbaum A, Rovin J, Sanchez C, Szerlip M, Deeb GM, Amoroso N, Patel D, Fahy M, Ranard LS, Gupta A, Chakravarty T, Skaf S, Chuang M, Kodali SK, Figulla HR, Treede H, Baldus S, Pinto DS, Leon MB; ALIGN-AR Investigators. Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet. 2025 Dec 13;406(10521):2757-2771. doi: 10.1016/S0140-6736(25)02215-9. Epub 2025 Nov 16.
PubMed 41260228Sanchez-Luna JP, Martin P, Dager AE, Charry PD, Beltran JR, Sanchez-Recalde A, Giannini F, Gomez-Menchero A, Pan M, Ielasi A, Monastyrski A, Barbanti M, Fernandez-Aviles F, Ancona MB, Mussayev A, De Brahi JP, Lamelas P, Sanchez-Perez A, Garcia Puerta M, Ortiz M, Gonzalez-Gutierrez JC, Marengo G, Gomez J, Gonzalez-Bartol E, Stepanenko A, Gomez-Salvador I, San Roman JA, Amat-Santos IJ. Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation. EuroIntervention. 2023 Sep 18;19(7):580-588. doi: 10.4244/EIJ-D-23-00344.
PubMed 37565470Koren O, Patel V, Naami R, Naami E, Nagasaka T, Shechter A, Natanzon SS, Kohan S, Allison Z, Lerner A, Cheng DE, Chakravarty T, Nakamura M, Cheng W, Jilaihawi H, Makkar RR. New adverse coronary events in valve-in-valve TAVR and native TAVR-A 2-year matched cohort. Front Cardiovasc Med. 2022 Sep 21;9:1004103. doi: 10.3389/fcvm.2022.1004103. eCollection 2022.
PubMed 36211543