4D- Flow- MRI After Aortic Valve Surgery

Changes of Aortic Flow Patterns Detected by 4D- Flow- MRI After Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium Compared to Prosthetic Valve Replacement With Biological Prosthesis

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Procedure: TriRec; Procedure: Aortic valve replacement

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Recruiting
    • Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery
    • Contact: Anatol Prinzing, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 50 years
• Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
• Aortic annulus > 19 mm
• Written informed consent of the patients.

Exclusion Criteria:

• Concomitant intervention of the aortic root, ascending aorta or aortic arch
• Concomitant valve surgery
• Emergency surgery for any reason
• Neurological events (i.e. stroke, TIA) within the previous 6 months
• Coagulation disorders (including thrombocytopenia < 100.000/ml)
• Porcelain aorta/severe calcification of the ascending aorta
• Active endocarditis or other active systemic infections
• Participating in another trial that may influence the outcome of this trial
• Pregnancy
• Dual antiplatelet therapy
• Previous cardiac surgery (excluding percutaneous procedures)
• Contraindication for MRI- examinations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TriRec; Trileaflet Reconstruction of the Aortic Valve	Procedure: TriRec; Trileaflet Reconstruction of the Aortic Valve
EXPERIMENTAL: Aortic valve replacement; Biological prosthesis, Device: Edwards Perimount	Procedure: Aortic valve replacement; Biological Prosthesis, Device: Edwards Perimount

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow velocity in the ascending aorta (m/s)	Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI.	Day 4-7 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow vortices	Flow vortices: defined as rotating particles around a point within the vessel with the rotational direction diverting > 90° from the physiological flow direction.	Day 4-7 post surgery
Flow helicality	Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure	Day 4-7 post surgery
Systolic eccentricity	Localization of the main blood flow vector (central, little, severe eccentricity).	Day 4-7 post surgery
Flow patterns in the left ventricular outflow tract.	Flow patterns in the left ventricular outflow tract.	Day 4-7 post surgery
Effective orifice area (4D-Flow-MRI)	Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI)	Day 4-7 post surgery
Effective orifice area (TTE)	Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE)	Day 4-7 post surgery
Peak- and mean pressure gradients (mmHg, TTE)	Peak- and mean pressure gradients (mmHg, TTE)	Day 4-7 post surgery
Left- ventricular diameters (mm, TTE)	Left- ventricular diameters (mm, TTE)	Day 4-7 post surgery
Left- ventricular ejection fraction (%, TTE)	Left- ventricular ejection fraction (%, TTE)	Day 4-7 post surgery
Quantification of aortic regurgitation (MRI)	Quantification of aortic regurgitation (MRI)	Day 4-7 post surgery
Quantification of aortic regurgitation (TTE)	Quantification of aortic regurgitation (TTE)	Day 4-7 post surgery

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2020
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (ACTUAL): January 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: MRI; aortic stenosis; aortic regurgitation; Trileaflet reconstruction of the aortic valve; Biological aortic valve prosthesis; aortic flow patterns
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 77/19-S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No