NCT05438862

Brief Summary

The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2022Dec 2027

First Submitted

Initial submission to the registry

June 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

June 21, 2022

Last Update Submit

February 13, 2026

Conditions

Aortic Valve Regurgitation

Keywords

aortic regurgitationcardiac magnetic resonanceechocardiographyearly surgical intervention

Outcome Measures

Primary Outcomes (1)

  • Composite safety and efficacy endpoint at 12 months post-randomization (all 3 criteria must be fulfilled):

    1. Reverse LV remodelling (CMR-derived EDVI decrease \>15% compared to baseline) 2. LV ejection fraction \>50% 3. Absence of MACE (cardiovascular mortality, stroke, myocardial infarction, heart failure, infective endocarditis)

    12 months

Secondary Outcomes (7)

  • Change in comparison to baseline:

    12 months

  • Change in comparison to baseline:

    12 months

  • Normalization of N-terminal pro B-natriuretic peptide serum level

    12 months

  • In hospital and 30 days mortality

    30 day postoperatively

  • Time to cardiovascular death

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Early surgery

EXPERIMENTAL

Early surgical treatment, state of art aortic valve surgery.

Procedure: State of art aortic valve surgery

Watchful waiting

NO INTERVENTION

Watchful waiting strategy, regular follow-up of patients with severe valve disease. Guideline-based indication for surgery only during the follow-up.

Interventions

State of art aortic valve surgeryPROCEDURE

Optimal surgical treatment (aortic valve-sparing surgery, aortic valve replacement, Ross procedure).

Early surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe)
  • No indication for the surgical treatment at the time of enrolment
  • LV ejection fraction \>50%
  • Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease

You may not qualify if:

  • Age \<18 years
  • Clearance Creatinine \<30 mL/min
  • Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue)
  • Pregnancy
  • Permanent atrial fibrillation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cardiovascular Center OLV Clinic Aalst

Aalst, 9300, Belgium

RECRUITING

International Clinical Research Center, St. Anne´s University Hospital Brno

Brno, 656 91, Czechia

ACTIVE NOT RECRUITING

Center of Cardiovascular and Transplant Surgery

Brno, 65691, Czechia

RECRUITING

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

RECRUITING

2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague

Prague, 128 08, Czechia

RECRUITING

Na Homolce Hospital

Prague, 150 30, Czechia

RECRUITING

Nemocnice AGEL Třinec-Podlesí

Třinec, 73961, Czechia

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Related Publications (17)

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    PMID: 31510787RESULT

  • Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.

    PMID: 34453165RESULT

  • Michelena HI, Prakash SK, Della Corte A, Bissell MM, Anavekar N, Mathieu P, Bosse Y, Limongelli G, Bossone E, Benson DW, Lancellotti P, Isselbacher EM, Enriquez-Sarano M, Sundt TM 3rd, Pibarot P, Evangelista A, Milewicz DM, Body SC; BAVCon Investigators. Bicuspid aortic valve: identifying knowledge gaps and rising to the challenge from the International Bicuspid Aortic Valve Consortium (BAVCon). Circulation. 2014 Jun 24;129(25):2691-704. doi: 10.1161/CIRCULATIONAHA.113.007851. No abstract available.

    PMID: 24958752RESULT

  • Carabello BA. The relationship of left ventricular geometry and hypertrophy to left ventricular function in valvular heart disease. J Heart Valve Dis. 1995 Oct;4 Suppl 2:S132-8; discussion S138-9.

    PMID: 8563989RESULT

  • Villari B, Campbell SE, Hess OM, Mall G, Vassalli G, Weber KT, Krayenbuehl HP. Influence of collagen network on left ventricular systolic and diastolic function in aortic valve disease. J Am Coll Cardiol. 1993 Nov 1;22(5):1477-84. doi: 10.1016/0735-1097(93)90560-n.

    PMID: 8227808RESULT

  • de Meester C, Gerber BL, Vancraeynest D, Pouleur AC, Noirhomme P, Pasquet A, de Kerchove L, El Khoury G, Vanoverschelde JL. Do Guideline-Based Indications Result in an Outcome Penalty for Patients With Severe Aortic Regurgitation? JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2126-2138. doi: 10.1016/j.jcmg.2018.11.022. Epub 2019 Jan 16.

    PMID: 30660551RESULT

  • Desai MY. Aortic regurgitation: are we operating too late? Ann Cardiothorac Surg. 2019 May;8(3):390-392. doi: 10.21037/acs.2019.04.06. No abstract available.

    PMID: 31240183RESULT

  • Dujardin KS, Enriquez-Sarano M, Schaff HV, Bailey KR, Seward JB, Tajik AJ. Mortality and morbidity of aortic regurgitation in clinical practice. A long-term follow-up study. Circulation. 1999 Apr 13;99(14):1851-7. doi: 10.1161/01.cir.99.14.1851.

    PMID: 10199882RESULT

  • Mentias A, Feng K, Alashi A, Rodriguez LL, Gillinov AM, Johnston DR, Sabik JF, Svensson LG, Grimm RA, Griffin BP, Desai MY. Long-Term Outcomes in Patients With Aortic Regurgitation and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2016 Nov 15;68(20):2144-2153. doi: 10.1016/j.jacc.2016.08.045.

    PMID: 27855803RESULT

  • David TE, Feindel CM, Webb GD, Colman JM, Armstrong S, Maganti M. Long-term results of aortic valve-sparing operations for aortic root aneurysm. J Thorac Cardiovasc Surg. 2006 Aug;132(2):347-54. doi: 10.1016/j.jtcvs.2006.03.053. Epub 2006 Jul 10.

    PMID: 16872961RESULT

  • Lansac E, de Kerchove L. Aortic valve repair techniques: state of the art. Eur J Cardiothorac Surg. 2018 Jun 1;53(6):1101-1107. doi: 10.1093/ejcts/ezy176. No abstract available.

    PMID: 29718164RESULT

  • Myerson SG, d'Arcy J, Mohiaddin R, Greenwood JP, Karamitsos TD, Francis JM, Banning AP, Christiansen JP, Neubauer S. Aortic regurgitation quantification using cardiovascular magnetic resonance: association with clinical outcome. Circulation. 2012 Sep 18;126(12):1452-60. doi: 10.1161/CIRCULATIONAHA.111.083600. Epub 2012 Aug 9.

    PMID: 22879371RESULT

  • Kockova R, Linkova H, Hlubocka Z, Praveckova A, Polednova A, Sukupova L, Blaha M, Maly J, Honsova E, Sedmera D, Penicka M. New Imaging Markers of Clinical Outcome in Asymptomatic Patients with Severe Aortic Regurgitation. J Clin Med. 2019 Oct 11;8(10):1654. doi: 10.3390/jcm8101654.

    PMID: 31614523RESULT

  • Steeds RP, Myerson SG. Imaging assessment of mitral and aortic regurgitation: current state of the art. Heart. 2020 Nov;106(22):1769-1776. doi: 10.1136/heartjnl-2019-316216. Epub 2020 Aug 17. No abstract available.

    PMID: 32817242RESULT

  • Kockova R, Kacer P, Pirk J, Maly J, Sukupova L, Sikula V, Kotrc M, Barciakova L, Honsova E, Maly M, Kautzner J, Sedmera D, Penicka M. Native T1 Relaxation Time and Extracellular Volume Fraction as Accurate Markers of Diffuse Myocardial Fibrosis in Heart Valve Disease - Comparison With Targeted Left Ventricular Myocardial Biopsy. Circ J. 2016 Apr 25;80(5):1202-9. doi: 10.1253/circj.CJ-15-1309. Epub 2016 Mar 17.

    PMID: 26984717RESULT

  • Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.

    PMID: 28314623RESULT

  • Vecera J, Bartunek J, Vanderheyden M, Kotrc M, Kockova R, Penicka M. Three-dimensional echocardiography-derived vena contracta area at rest and its increase during exercise predicts clinical outcome in mild-moderate functional mitral regurgitation. Circ J. 2014;78(11):2741-9. doi: 10.1253/circj.cj-14-0183. Epub 2014 Oct 3.

    PMID: 25283687RESULT

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Radka Kočková, MD, PhD

    Na Homolce Hospital

    PRINCIPAL INVESTIGATOR

  • Jan Vojáček, MD, PhD

    Faculty Hospital Hradec Králové

    PRINCIPAL INVESTIGATOR

  • Martin Pěnička, MD, PhD

    Cardiovascular Center OLV Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Radka Kočková, MD,PhD

CONTACT

+420606483586radka.kockova@centrum.cz

Jan Vojáček, MD, PhD

CONTACT

+420777095921jan.vojacek1@fnhk.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization between early surgical and conventional watchful waiting strategy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 30, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Publication of the rationale and design of the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12 months
Access Criteria
National Library of Medicine
More information

Locations

BE(1)CZ(6)SE(1)