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Aortic Regurgitation clinical trials

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NCT ID: NCT05774808 Completed - Clinical trials for Functional Mitral Regurgitation

Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation

Start date: February 2, 2022
Phase:
Study type: Observational

Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case. When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team. To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients. The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.

NCT ID: NCT05774795 Completed - Clinical trials for Mitral Regurgitation

LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery

Start date: March 24, 2021
Phase:
Study type: Observational

Multivalvular heart disease is a highly prevalent clinical condition that comprises 14.6% of the patients undergoing valvular surgery. Specifically, aortic valve regurgitation (AR) can be present in a considerable proportion of patients undergoing mitral valve (MV) surgery. In the Society of Thoracic Surgeons database, con- comitant aortic and mitral surgery accounted for 57.8% of the total multivalvular procedures with an unadjusted mortality rate of 10.7%. When both the aortic and MVs exhibit severe disease, con- comitant valve surgery is well-accepted by the surgical commu- nity and supported by current guidelines. On the other hand, when the aortic valve (AV) shows only moderate regurgita- tion, which would not be surgically treated if singly present, the appropriate management of the AV pathology at the time of MV surgery is still under debate. The American College of Cardiology guidelines state that aortic valve replacement (AVR) is reasonable (class IIa) in patients with moderate AR (stage B) while undergoing surgery on the ascend- ing aorta, a coronary artery bypass graft or MV surgery (level of evidence: C). Conversely, the latest European Society of Cardiology guidelines on valvular heart disease define as con- troversial the decision to treat the AV in patients with moderate AR who undergo MV surgery, considering the slow progression of this disease. In this group of patients, they advocate a heart team approach that will take into account the aetiology of AR, the life expectancy of the patient, the operative risk and other clinical factors. This disagreement may lead to uncertainty about how patients with less than severe AR should be managed during MV surgery, especially considering the burden of double-valve surgical procedures. The goal of this study is to evaluate the immediate and long- term outcomes, including the need for a new procedure on the AV, in patients with moderate AR at the time of MV surgery.

NCT ID: NCT05515848 Completed - Clinical trials for Aortic Regurgitation

Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David

AORTLANTIC
Start date: November 7, 2021
Phase:
Study type: Observational

Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six centers (Nantes - Rennes - Brest - Angers - Tours [two centers]). The main objective of this study is to evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI).

NCT ID: NCT05332184 Completed - Clinical trials for Aortic Regurgitation

Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation

Start date: July 1, 2016
Phase:
Study type: Observational

To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.

NCT ID: NCT03666351 Completed - Hypertension Clinical Trials

Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease

Start date: October 18, 2018
Phase: Phase 4
Study type: Interventional

To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety

NCT ID: NCT03314857 Completed - Aortic Stenosis Clinical Trials

China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population

Start date: September 18, 2017
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

NCT ID: NCT02283970 Completed - Clinical trials for Aortic Regurgitation

Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)

VAR
Start date: December 2012
Phase:
Study type: Observational

Prospective longitudinal study on four small groups of surgical patients affected by: BAV with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with isolated stenosis in over 60 year-old patients. The aim of the study is to select homogeneous small groups of surgical patients with the same subtype of BAV and same aortic behaviour and identify markers/predictors of favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more likely to be considered at high risk for aortic degeneration.

NCT ID: NCT01598844 Completed - Aortic Stenosis Clinical Trials

JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

JUPITER
Start date: May 30, 2012
Phase:
Study type: Observational

The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.

NCT ID: NCT01400841 Completed - Clinical trials for Aortic Regurgitation

HAART Model 300 Annuloplasty Ring

Start date: January 2012
Phase: N/A
Study type: Interventional

This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame

NCT ID: NCT00976625 Completed - Clinical trials for Aortic Regurgitation

Diastolic Dysfunction in Aortic Regurgitation

Start date: January 1996
Phase: N/A
Study type: Interventional

Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.