Clinical Trials Logo
  1. Home
  2. Aortic Valve Stenosis
  3. NCT03411304
  4. Details
NCT03411304 Clinical Trial

Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement

Aortic Valve Stenosis Clinical Trial

Official title:
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03411304
Other study ID # 2017/080/HP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 5, 2017
Est. completion date June 2025

Study information
Verified date May 2023
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified. The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 440
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aortic stenosis - Indication of Aortic Valve Replacement (Surgery or TAVI) Exclusion Criteria: - Rheumatismal or congenital aortic stenosis - Aortic insufficiency (grade >= 2/4) - Associated valvulopathy (grade >= 2/4) - Myocardial infarction antecedent - Severe renal failure - Cardiac surgery (Aorta abdominal) antecedent - Complex congenital cardiopathy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France UH Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 1
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 2
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 3
Primary Occurrence of clinical events according to left ventricular remodeling Echocardiography and MRI Year 4
Secondary Evolution of left ventricular remodeling after aortic valvular replacement Echocardiography and MRI Year 1
Secondary Prognostic value of persistence and type of left ventricular remodeling Echocardiography and MRI Occurence of clinical events Year 1
Secondary Prognostic value of fibrosis Echocardiography and MRI Occurence of clinical events Year 1
Secondary Prognostic value of biomarkers Year 1
See also
  Status Clinical Trial Phase
Completed NCT03186339 - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Terminated NCT02854319 - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System N/A
Recruiting NCT05601453 - The ReTAVI Prospective Observational Registry
Withdrawn NCT05481814 - CPX in Paradoxical Low Flow Aortic Stenosis
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Completed NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Active, not recruiting NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease