Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation
NCT ID: NCT05438862
Last Updated: 2026-02-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
217 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-09-01
Study Completion Date
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Novel Cardiac Imaging Prognostic Markers of Clinical Outcome in Patients With Chronic Aortic Regurgitation
NCT02910349
Aortic Valve Disorder
COMPLETED
Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation
NCT01703806
Mitral Regurgitation
COMPLETED
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
NCT06805253
Aortic Valve Regurgitation
Mitral Valve Regurgitation
Left Ventricle Dilated
+3 more
RECRUITING
Early Surgery for Patients With Asymptomatic Aortic Stenosis
NCT02627391
Aortic Valve Stenosis
Aortic Valve Surgery
UNKNOWN
NA
Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease
NCT05044377
Aortic Valve Disease
UNKNOWN
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Introduction:
Aortic regurgitation (AR) is the third most frequent valvular heart disease in Western countries affecting rather young patients, mostly men. The degenerative process on the trileaflet aortic valve is the main cause of AR, followed by a congenital valve disease, typically bicuspid aortic valve. The high prevalence of bicuspid aortic valve in the general population which is frequently associated with aortic dilatation, another important cause of AR, can explain the unusual distribution of significant AR mainly among the population of males in their average 5th decade. Infective or rheumatic endocarditis and aortic dissection are less frequent reasons for AR.
Hemodynamically significant AR leads to volume and pressure overload of the left ventricle (LV). Severe LV dilatation and moderate LV hypertrophy are the main compensatory mechanisms that help to maintain cardiac output and relieve the increased LV wall stress. Doubling the cardiomyocyte size is accompanied by an increase in extracellular volume, including multiplying collagen fibres and increasing the volume of the non-collagen extracellular matrix. Untreated severe AR leads to advanced LV remodeling and LV dysfunction causing the development of heart failure.
The only appropriate treatment for chronic haemodynamically significant AR is aortic valve surgery. The indications for AR surgical treatment are summarized in the 2021 ESC/EATS Guidelines for the management of the valvular disease. Class I indications of aortic valve surgery are based on the presence of symptoms of heart failure (exertional dyspnoea, chest tightness) and/or presence of severe LV remodelling (LV ejection fraction ≤50% or LV end-systolic diameter (ESD) \>50 mm or LV ESD Index \>25 mm/m2 in patients with small body size). There is increasing evidence that patients undergoing surgery at such an advanced stage of the disease have already irreversible myocardial damage. There is also evidence that surgical risk in a relatively younger and low-risk population has decreased with novel surgical techniques and perioperative care, including aortic valve-sparing surgery with documented excellent long-term effects. Concerning these facts, it might be reasonable to shift the surgical treatment towards an earlier stage of the disease.
Available evidence including our study suggests higher clinical accuracy of cardiac magnetic resonance (CMR)-derived AR quantification than that of the guidelines-based echocardiographic (ECHO) Integrative approach (12-14). Severe AR defined as regurgitation fraction (RF) \>33% and/or regurgitant volume (RV) \>44 ml with LV dilatation defined as LV end-diastolic volume index (LVEDVI) \>123 ml/m2 present the most accurate marker of early disease progression requiring surgery in a median of 399 (IQR 209) days (unpublished data).
Project Hypothesis:
1. We hypothesize that early surgical treatment will lead to early LV reverse remodeling, leading to the complete normalization of LV structure and function.
2. We hypothesize that early surgical treatment in patients with low surgical risk and severe AR as per CMR assessment will be a superior, safe procedure with a low incidence of early and late periprocedural complications in comparison to standard published data from large centres.
3. We hypothesize that early surgical treatment will lead to early improvement in quality of life and exercise performance in the majority of patients.
4. We hypothesize that early surgical treatment will be associated with lower long-term cardiovascular morbidity.
Project Plan:
1. All consecutive patients referred to the participating centre for a hemodynamically significant chronic AR will be screened. Patients with AR grade 3 and grade 4 without an indication for aortic valve surgery as per current Guidelines and who comply with the inclusion and exclusion criteria will be offered to participate in the study.
2. All patients will undergo CMR at baseline and after 12 months, including T1 mapping, contrast-enhanced imaging and flow sequence measurement at sinotubular junction according to study protocol in a particular centre. All CMR studies will be anonymized and digitally transferred to CoreLab based in University Hospital Hradec Králové. The off-line analysis will consist of the left and right ventricular volumes, mass and ejection fraction calculation. AR will be quantified utilising flow sequence measurement at the sinotubular junction. A correction for Eddy's current will be applied. Native T1 relaxation time will be measured in the midventricular septum.
3. All patients will undergo a comprehensive 2-dimensional (2D) and 3-dimensional (3D) ECHO at baseline and every six months of follow-up in each participating centre. Echocardiography will be performed using Vivid 7, Vivid E9, and Vivid E95 (GE Healthcare, Horten, Norway) to allow for advanced analysis. The off-line analysis will include the left ventricular volume, mass, ejection fraction and global longitudinal strain calculation. Aortic regurgitation will be quantified utilizing a widely accepted Integrative approach. Vena contracta area will be measured whenever possible. Moreover, baseline and 12-month images will be analysed centrally by one operator (Cardiovascular Center, Aalst, Belgium).
4. All patients will undergo 12-lead electrocardiography (ECG) and blood sample analysis at baseline and every six months of follow-up in each participating centre. One blood sample (serum and plasma) will be stored frozen at -80 C° for further analysis.
5. All patients will undergo an exercise stress test - spiroergometry (CPET) - at baseline and a 12-month follow-up in each participating centre. CPET will be used to validate asymptomatic status and to assess changes in exercise performance during follow-up.
6. All patients will fill out the questionnaire (RAND 36-Item Health Survey 1.0 Questionnaire Items) at baseline and 12 months after randomization.
6\. Randomization will be computer-based, utilizing the covariate adaptive randomization method to achieve a balanced distribution of both patients' groups in between participating centres, age and gender.
7\. Aortic valve surgery will be performed in each participating centre by an experienced surgeon who is a member of the study team. The type of surgery will be based on a "state of art" approach and local expertise with the preference for valve-sparing surgery or Ross procedure in carefully selected patients. Transesophageal ECHO will be performed in all patients to evaluate valve morphology and suitability for valve-sparing surgery. The surgery will be scheduled within 3 months after randomization for early surgery. Patients in the watchful waiting group study arm will undergo surgical treatment in agreement with current Guidelines for the disease progression during the study follow-up.
Methods:
Design The study will be prospective, randomized and multicenter, including international collaboration. Imaging data will be analyzed in a CoreLab based in the Czech Republic for CMR data (Faculty Hospital Hradec Králové) and Belgium for ECHO data (Cardiovascular Center Aalst).
Patients Patients with chronic grade 3 and grade 4 AR without an indication for surgical treatment as per current Guidelines will be enrolled in the study after signing the informed consent. The baseline examination consists of a clinical examination, ECG, blood test analysis (including N-terminal pro-brain natriuretic peptide), a comprehensive 2D and 3D ECHO, exercise stress test (CPET preferably) and CMR.
Patients with CMR-derived RF \>35% or RV \>45 ml and LV EDVI \>125 mL/m2 will be randomised in a 1:1 ratio between early surgery (Group A) or watchful waiting (Group B). Patients, not fulfilling these CMR criteria, will enter the registry (Group C).
Patients in Group A will undergo aortic valve surgery within 3 months after randomisation. Their follow-up will consist of a repeat CMR and spiroergometry 12 months after enrolment. The regular follow-up will be every 6 months including a clinical examination, 2D and 3D ECHO and blood tests. Patients who will decline early surgical treatment might be reassigned to Group B but the total number must not exceed 6% of the total number of enrolled patients in a particular centre. The results will be statistically tested for both, intention to treat and as treated.
Patients in Group B and C will be reviewed every 6 months including a clinical examination, 2D and 3D ECHO and blood tests. A repeat CMR study and spiroergometry will be performed 12 months after enrolment. Patients who develop an indication for aortic valve surgery as per current Guidelines during the watchful waiting period of the study will undergo aortic valve surgery within 3 months after the onset of the indication.
Aortic regurgitation (AR) is the third most frequent valvular heart disease in Western countries affecting rather young patients, mostly men. The degenerative process on the trileaflet aortic valve is the main cause of AR, followed by a congenital valve disease, typically bicuspid aortic valve. The high prevalence of bicuspid aortic valve in the general population which is frequently associated with aortic dilatation, another important cause of AR, can explain the unusual distribution of significant AR mainly among the population of males in their average 5th decade. Infective or rheumatic endocarditis and aortic dissection are less frequent reasons for AR.
Hemodynamically significant AR leads to volume and pressure overload of the left ventricle (LV). Severe LV dilatation and moderate LV hypertrophy are the main compensatory mechanisms that help to maintain cardiac output and relieve the increased LV wall stress. Doubling the cardiomyocyte size is accompanied by an increase in extracellular volume, including multiplying collagen fibres and increasing the volume of the non-collagen extracellular matrix. Untreated severe AR leads to advanced LV remodeling and LV dysfunction causing the development of heart failure.
The only appropriate treatment for chronic haemodynamically significant AR is aortic valve surgery. The indications for AR surgical treatment are summarized in the 2021 ESC/EATS Guidelines for the management of the valvular disease. Class I indications of aortic valve surgery are based on the presence of symptoms of heart failure (exertional dyspnoea, chest tightness) and/or presence of severe LV remodelling (LV ejection fraction ≤50% or LV end-systolic diameter (ESD) \>50 mm or LV ESD Index \>25 mm/m2 in patients with small body size). There is increasing evidence that patients undergoing surgery at such an advanced stage of the disease have already irreversible myocardial damage. There is also evidence that surgical risk in a relatively younger and low-risk population has decreased with novel surgical techniques and perioperative care, including aortic valve-sparing surgery with documented excellent long-term effects. Concerning these facts, it might be reasonable to shift the surgical treatment towards an earlier stage of the disease.
Available evidence including our study suggests higher clinical accuracy of cardiac magnetic resonance (CMR)-derived AR quantification than that of the guidelines-based echocardiographic (ECHO) Integrative approach (12-14). Severe AR defined as regurgitation fraction (RF) \>33% and/or regurgitant volume (RV) \>44 ml with LV dilatation defined as LV end-diastolic volume index (LVEDVI) \>123 ml/m2 present the most accurate marker of early disease progression requiring surgery in a median of 399 (IQR 209) days (unpublished data).
Project Hypothesis:
1. We hypothesize that early surgical treatment will lead to early LV reverse remodeling, leading to the complete normalization of LV structure and function.
2. We hypothesize that early surgical treatment in patients with low surgical risk and severe AR as per CMR assessment will be a superior, safe procedure with a low incidence of early and late periprocedural complications in comparison to standard published data from large centres.
3. We hypothesize that early surgical treatment will lead to early improvement in quality of life and exercise performance in the majority of patients.
4. We hypothesize that early surgical treatment will be associated with lower long-term cardiovascular morbidity.
Project Plan:
1. All consecutive patients referred to the participating centre for a hemodynamically significant chronic AR will be screened. Patients with AR grade 3 and grade 4 without an indication for aortic valve surgery as per current Guidelines and who comply with the inclusion and exclusion criteria will be offered to participate in the study.
2. All patients will undergo CMR at baseline and after 12 months, including T1 mapping, contrast-enhanced imaging and flow sequence measurement at sinotubular junction according to study protocol in a particular centre. All CMR studies will be anonymized and digitally transferred to CoreLab based in University Hospital Hradec Králové. The off-line analysis will consist of the left and right ventricular volumes, mass and ejection fraction calculation. AR will be quantified utilising flow sequence measurement at the sinotubular junction. A correction for Eddy's current will be applied. Native T1 relaxation time will be measured in the midventricular septum.
3. All patients will undergo a comprehensive 2-dimensional (2D) and 3-dimensional (3D) ECHO at baseline and every six months of follow-up in each participating centre. Echocardiography will be performed using Vivid 7, Vivid E9, and Vivid E95 (GE Healthcare, Horten, Norway) to allow for advanced analysis. The off-line analysis will include the left ventricular volume, mass, ejection fraction and global longitudinal strain calculation. Aortic regurgitation will be quantified utilizing a widely accepted Integrative approach. Vena contracta area will be measured whenever possible. Moreover, baseline and 12-month images will be analysed centrally by one operator (Cardiovascular Center, Aalst, Belgium).
4. All patients will undergo 12-lead electrocardiography (ECG) and blood sample analysis at baseline and every six months of follow-up in each participating centre. One blood sample (serum and plasma) will be stored frozen at -80 C° for further analysis.
5. All patients will undergo an exercise stress test - spiroergometry (CPET) - at baseline and a 12-month follow-up in each participating centre. CPET will be used to validate asymptomatic status and to assess changes in exercise performance during follow-up.
6. All patients will fill out the questionnaire (RAND 36-Item Health Survey 1.0 Questionnaire Items) at baseline and 12 months after randomization.
6\. Randomization will be computer-based, utilizing the covariate adaptive randomization method to achieve a balanced distribution of both patients' groups in between participating centres, age and gender.
7\. Aortic valve surgery will be performed in each participating centre by an experienced surgeon who is a member of the study team. The type of surgery will be based on a "state of art" approach and local expertise with the preference for valve-sparing surgery or Ross procedure in carefully selected patients. Transesophageal ECHO will be performed in all patients to evaluate valve morphology and suitability for valve-sparing surgery. The surgery will be scheduled within 3 months after randomization for early surgery. Patients in the watchful waiting group study arm will undergo surgical treatment in agreement with current Guidelines for the disease progression during the study follow-up.
Methods:
Design The study will be prospective, randomized and multicenter, including international collaboration. Imaging data will be analyzed in a CoreLab based in the Czech Republic for CMR data (Faculty Hospital Hradec Králové) and Belgium for ECHO data (Cardiovascular Center Aalst).
Patients Patients with chronic grade 3 and grade 4 AR without an indication for surgical treatment as per current Guidelines will be enrolled in the study after signing the informed consent. The baseline examination consists of a clinical examination, ECG, blood test analysis (including N-terminal pro-brain natriuretic peptide), a comprehensive 2D and 3D ECHO, exercise stress test (CPET preferably) and CMR.
Patients with CMR-derived RF \>35% or RV \>45 ml and LV EDVI \>125 mL/m2 will be randomised in a 1:1 ratio between early surgery (Group A) or watchful waiting (Group B). Patients, not fulfilling these CMR criteria, will enter the registry (Group C).
Patients in Group A will undergo aortic valve surgery within 3 months after randomisation. Their follow-up will consist of a repeat CMR and spiroergometry 12 months after enrolment. The regular follow-up will be every 6 months including a clinical examination, 2D and 3D ECHO and blood tests. Patients who will decline early surgical treatment might be reassigned to Group B but the total number must not exceed 6% of the total number of enrolled patients in a particular centre. The results will be statistically tested for both, intention to treat and as treated.
Patients in Group B and C will be reviewed every 6 months including a clinical examination, 2D and 3D ECHO and blood tests. A repeat CMR study and spiroergometry will be performed 12 months after enrolment. Patients who develop an indication for aortic valve surgery as per current Guidelines during the watchful waiting period of the study will undergo aortic valve surgery within 3 months after the onset of the indication.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Aortic Valve Regurgitation
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomization between early surgical and conventional watchful waiting strategy.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early surgery
Early surgical treatment, state of art aortic valve surgery.
Group Type
EXPERIMENTAL
State of art aortic valve surgery
Intervention Type
PROCEDURE
Optimal surgical treatment (aortic valve-sparing surgery, aortic valve replacement, Ross procedure).
Watchful waiting
Watchful waiting strategy, regular follow-up of patients with severe valve disease. Guideline-based indication for surgery only during the follow-up.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
State of art aortic valve surgery
Optimal surgical treatment (aortic valve-sparing surgery, aortic valve replacement, Ross procedure).
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Hradec Kralove
OTHER
Sponsor Role
collaborator
Centre of Cardiovascular and Transplantation Surgery, Czech Republic
OTHER
Sponsor Role
collaborator
St. Anne's University Hospital Brno, Czech Republic
OTHER
Sponsor Role
collaborator
VZW Cardiovascular Research Center Aalst
OTHER
Sponsor Role
collaborator
General University Hospital, Prague
OTHER
Sponsor Role
collaborator
University Clinical Centre of Republic of Srpska
OTHER
Sponsor Role
collaborator
AGEL Třinec-Podlesí Hospital
UNKNOWN
Sponsor Role
collaborator
Na Homolce Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Radka Kockova, MD, Ph.D.
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Radka Kočková, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Na Homolce Hospital
Jan Vojáček, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty Hospital Hradec Králové
Martin Pěnička, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Center OLV Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiovascular Center OLV Clinic Aalst
Aalst, , Belgium
Site Status
RECRUITING
International Clinical Research Center, St. Anne´s University Hospital Brno
Brno, , Czechia
Site Status
ACTIVE_NOT_RECRUITING
Center of Cardiovascular and Transplant Surgery
Brno, , Czechia
Site Status
RECRUITING
University Hospital Hradec Králové
Hradec Králové, , Czechia
Site Status
RECRUITING
2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague, , Czechia
Site Status
RECRUITING
Na Homolce Hospital
Prague, , Czechia
Site Status
RECRUITING
Nemocnice AGEL Třinec-Podlesí
Třinec, , Czechia
Site Status
RECRUITING
University Clinical Center of Serbia
Belgrade, , Serbia
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Belgium
Czechia
Serbia
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Iung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, De Bonis M, Tribouilloy C, Evangelista A, Bogachev-Prokophiev A, Apor A, Ince H, Laroche C, Popescu BA, Pierard L, Haude M, Hindricks G, Ruschitzka F, Windecker S, Bax JJ, Maggioni A, Vahanian A; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019 Oct;140(14):1156-1169. doi: 10.1161/CIRCULATIONAHA.119.041080. Epub 2019 Sep 12.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6.4.2022/5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root
NCT05167539
UNKNOWN
Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds
NCT06782620
COMPLETED
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
NCT03389542
RECRUITING
NA
Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis
NCT02436655
COMPLETED
NA
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
NCT03143361
RECRUITING
Diastolic Dysfunction in Aortic Regurgitation
NCT00976625
COMPLETED
NA
Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)
NCT04900909
COMPLETED
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
NCT05310461
RECRUITING
NA
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
NCT06381271
RECRUITING
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
NCT01161732
COMPLETED
NA
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
NCT05774808
COMPLETED
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
NCT03667365
TERMINATED
NA
The Fate of Aortic Valve After SAS Surgery in Children
NCT06751368
COMPLETED
LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery
NCT05774795
COMPLETED
Severe Aortic Stenosis in Patients Referred for Valve Surgery
NCT01794832
UNKNOWN
Surgical vs Transcatheter Aortic Valve Replacement in Young Patients
NCT06861361
RECRUITING
NA
MRI in Randomised Cohorts of Asymptomatic AS
NCT05178368
RECRUITING
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease
NCT04780607
UNKNOWN
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
NCT06255457
RECRUITING
Screening for Amyloidosis Before Aortic Valve Elective Replacement
NCT04869631
ACTIVE_NOT_RECRUITING
Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease
NCT02173860
UNKNOWN
NA
Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
NCT04613193
RECRUITING
NA
Minimally Invasive Aortic Root and Aorta surGery rEgistry
NCT04814238
UNKNOWN
Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR
NCT07148973
COMPLETED
The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study
NCT03155373
COMPLETED