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Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Magnetic Resonance Imaging

Primary Purpose

Tricuspid Valve Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Magnet resonance imaging
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tricuspid Valve Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.

Exclusion Criteria:

  • Patient with Incompatibility with magnetic resonance imaging or echocardiography
  • Another valve disorder that requires treatment
  • Severe precapillary pulmonary hypertension
  • Unstable angina or percutaneous coronary intervention within the last 30 days
  • Previous pacemaker/defibrillator implantation with intracardiac leads
  • Patients with cardiac cachexia or a life expectancy less then 12 months
  • Allergies to the material used.

Sites / Locations

  • Herz- und Diabeteszentrum, NRWRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MR-TTE

Arm Description

Patient receiving cardiac magnet resonance imaging and echocardiography

Outcomes

Primary Outcome Measures

Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention

Secondary Outcome Measures

Exercise Testing with 6 min walking test
Changes on walked distance after transcatheter tricuspid intervention
rehospitalization rate
Detection of rehospitalization rate after transcatheter tricuspid intervention
Stroke
Detection of stroke rate after transcatheter tricuspid intervention
Death due to cardiovascular complication
Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity
Changes on aerobic capacity and endurance using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram)

Full Information

First Posted
August 18, 2020
Last Updated
March 3, 2023
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT04522154
Brief Title
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Magnetic Resonance Imaging
Official Title
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Insufficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR-TTE
Arm Type
Other
Arm Description
Patient receiving cardiac magnet resonance imaging and echocardiography
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnet resonance imaging
Intervention Description
Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure
Primary Outcome Measure Information:
Title
Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
Description
Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
Description
Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention
Time Frame
3 Month
Title
Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
Description
Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention
Time Frame
3 Month
Title
Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
Description
Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Time Frame
3 Month
Title
Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
Description
Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention
Time Frame
3 Month
Title
Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
Description
Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention
Time Frame
3 Month
Title
Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
Description
Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Time Frame
3 Month
Secondary Outcome Measure Information:
Title
Exercise Testing with 6 min walking test
Description
Changes on walked distance after transcatheter tricuspid intervention
Time Frame
3 month
Title
rehospitalization rate
Description
Detection of rehospitalization rate after transcatheter tricuspid intervention
Time Frame
3 month
Title
Stroke
Description
Detection of stroke rate after transcatheter tricuspid intervention
Time Frame
3 month
Title
Death due to cardiovascular complication
Description
Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity
Description
Changes on aerobic capacity and endurance using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram)
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention. Exclusion Criteria: Patient with Incompatibility with magnetic resonance imaging or echocardiography Another valve disorder that requires treatment Severe precapillary pulmonary hypertension Unstable angina or percutaneous coronary intervention within the last 30 days Previous pacemaker/defibrillator implantation with intracardiac leads Patients with cardiac cachexia or a life expectancy less then 12 months Allergies to the material used.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammed Gercek, Dr. med
Phone
0049571971258
Email
mugercek@hdz-nrw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammed Gercek, Dr. med.
Organizational Affiliation
Assistant physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Diabeteszentrum, NRW
City
Bad Oeynhausen
State/Province
NRW
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammed Gercek, Dr. med
Phone
00495371971258
Email
mugercek@hdz-nrw.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Magnetic Resonance Imaging

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