4D- Flow- MRI After Aortic Valve Surgery

Status Recruiting

Clinical Trial Summary

This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.

Clinical Trial Description

Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. At the moment no prospective randomized trials evaluating the role of the TriRec procedure are available and factors contributing to long- term durability are unknown. The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis. The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Disease

Clinical Trial Details

NCT number	NCT04223713
Study type	Interventional
Source	Deutsches Herzzentrum Muenchen
Contact	Anatol Prinzing, MD
Phone	+49891218
Email	prinzing@dhm.mhn.de
Status	Recruiting
Phase	N/A
Start date	January 14, 2020
Completion date	August 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04149600` - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting	`NCT06001489` - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy	N/A
Not yet recruiting	`NCT04430972` - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed	`NCT02467062` - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Terminated	`NCT02128841` - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.	Phase 2
Active, not recruiting	`NCT01194362` - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting	`NCT05975567` - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting	`NCT06025149` - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed	`NCT05082337` - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures	N/A
Completed	`NCT05193760` - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting	`NCT05941455` - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting	`NCT03924661` - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed	`NCT04073875` - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting	`NCT03121053` - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement	Phase 4
Completed	`NCT02000544` - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit	N/A
Completed	`NCT02688153` - EDWARDS INTUITY Valve System CADENCE Study	N/A
Completed	`NCT02981004` - PAR I - Patient-to-Annulus Relation I
Recruiting	`NCT06126367` - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease