TAVR: the Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

Transcatheter Aortic Valve Implantation (TAVR): the Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries.

The main questions it aims to answer are:

1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment?
2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics?
3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Transcatheter Aortic Valve Replacement; Prosthesis Durability; Transcatheter Aortic Valve Implantation; Symmetry; Commissural Alignment; Commissural Misalignment; Prothesis Positioning
• Intervention / Treatment: Diagnostic test: transthoracic echocardiography

Detailed Description

Coming from a treatment option only for a high-risk cohort of elderly patients, transcatheter aortic valve replacement (TAVR) has become a safe and effective therapeutic approach for most patients with severe aortic valve stenosis (AS). Therefore, current guidelines recommend TAVR in patients from the age of 75 and even low surgical risk. Especially with the increasingly younger patient clientele, lifetime management is of utmost importance. Lifetime management includes, for example:

• Preserving coronary access after TAVR
• "Durability" of the new valve.
• Prevention of paravalvular leakage
• Prevention of atrioventricular blocks, which may necessitate a pacemaker.

The first two factors are particularly important and have therefore become the focus of the work.

Relating to this, the investigators would like to investigate three points:

1. Coronary access after TAVR is an important aspect for especially younger patients with longer life expectancy. The manufacturers try to address this task by offering techniques, which should help to orientate the novel commissures of the TAVR-valve within the native commissures of the diseased valve. Until now, the commissural alignment (CA) or misalignment (misCA) can only be depicted by post-TAVR cardiac computer tomography (CT) or selective coronary angiography, coming along with additional radiation and contrast medium exposure. Cardiovascular magnetic resonance imaging (CMRI) as well as transoesophageal echocardiography (TEE) may be alternative diagnostic options but have not been tested so far.
2. Transvalvular blood flow characteristics depending on the position of TAVR-prosthesis at the annular level may play a significant role concerning prothesis durability. However, it is unknown whether an asymmetric position or the presence of a CA may alter flow profile and therefore cause secondary endothelial stress leading to long term damage. With transthoracic echocardiography (TTE), TEE and CMRI the investigators would like to characterize flow patterns depending on symmetric vs. asymmetric valve position and CA vs. misCA.
3. It is not known what influence the TAVR position, more precisely a symmetric implantation and the presence of a CA, has on coronary flow and clinical outcomes. To investigate this, the investigators will record coronary flow in TEE and CMR after the implantation.

The results could be used in the future to detect CA or misCA and thereby evaluate and improve implantation techniques without harming the patient. Furthermore, if the investigators can identify advantages in symmetrically implanted TAVR with CA in terms of valve and coronary flow, techniques can be developed that target both symmetric and CA.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Zeus, Prof; Phone Number: 0211 81 18800; Email: zeus@med.uni-duesseldorf.de
• Study Contact Backup: Name: Kathrin Klein, Dr. med.; Phone Number: 0211 81 08252; Email: kathrin.klein@med-uni-duesseldorf.de

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
    • Contact: Tobias Zeus, Prof.; Phone Number: 0211 81 18801; Email: zeus@med.uni-duesseldorf.de
    • Contact: Kathrin Klein, MD; Phone Number: 0211 81 08252; Email: kathrin.klein@med.uni-duesseldorf.de
    • Contact: Ayse Sedef Ceylan, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).

Exclusion Criteria

• Any access route other than transfemoral.
• Valve-in-valve procedures.
• History of prior bioprosthetic valve implantation.
• Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system.
• Diagnosis of liver cirrhosis.
• Esophageal disorders, including but not limited to esophageal varices.
• Thrombocytopenia or coagulation disorders.
• Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TTE, TEE and MRI after TAVR; Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement.	Diagnostic test: transthoracic echocardiography; Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement.; Other Names: cardiac magnetic resonance imaging; Transoesophageal echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of a commissural alignment	by transoesophageal echocardiograpy and cardiac magnetic resonance imaging	Day 1
Presence of symmetrical position	by transoesophageal echocardiograpy and cardiac magnetic resonance imaging	Day 1
Transvalvular gradients	by Transthoracic echocardiography	baseline + day 1
Effective orifice area (EOA)	by Transthoracic echocardiography	baseline + day 1
Doppler velocity index	by Transthoracic echocardiography	baseline + day 1
Paravalvular leakage	by transoesophageal echocardiograpy	Day 1
Turbulent flow	by transoesophageal echocardiograpy and cardiac magnetic resonance imaging	baseline + day 1
Pressure recovery	by cardiac magnetic resonance imaging	Day 1
Energy loss coefficient	by transoesophageal echocardiograpy	Day 1
global coronary flow reserve	by cardiac magnetic resonance imaging	Day 1
Peak velocity	by cardiac magnetic resonance imaging	Day 1
Wall sheer stress	by cardiac magnetic resonance imaging	Day 1
Flow displacement	by cardiac magnetic resonance imaging	Day 1
aortic area	by cardiac magnetic resonance imaging	Day 1
volumen	by cardiac magnetic resonance imaging	Day 1
LV-Function	by transthoracic echocardiograpy and cardiac magnetic resonance imaging	baseline + day 1
RV-Function	by transthoracic echocardiograpy and cardiac magnetic resonance imaging	baseline + day 1
Strain	by transthoracic echocardiograpy	Day 1

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, Prof., Division of Cardiology, Pulmonary Disease and Vascular Medicine; Study Director: Tobias Zeus, Prof., Division of Cardiology, Pulmonary Disease and Vascular Medicine; Study Director: Kathrin Klein, Dr. med., Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Estimated): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: TEE; TAVI; TAVR; Symmetry; Commissural alignment; Prothesis positioning; cMRI; 4D Flow
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Disease; Aortic Valve Stenosis; Prosthesis Failure
• Other Study ID Numbers: CaS (DAL TKA registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No