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Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients (HERACLES-HFpEF)

Primary Purpose

Congestive Heart Failure, Tricuspid Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcatheter tricuspid valve edge-to-edge repair
Sponsored by
Heart Center Leipzig - University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestive Heart Failure focused on measuring Heart failure with preserved ejection fraction, tricuspid regurgitation, transcatheter tricuspid valve edge-to-edge repair

Eligibility Criteria

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

Inclusion Criteria:

  • Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
  • Signs and symptoms of left-sided heart failure.
  • Left-ventricular ejection fraction ≥50%
  • Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure [PCWP] or left-ventricular end-diastolic pressure ≥15 mmHg)

Exclusion Criteria:

  • Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
  • Moderate aortic stenosis.
  • Pregnancy
  • Contraindication to perform cardiac magnetic resonance imaging.
  • Conditions rendering patient unable to give informed consent to the study protocol.

Sites / Locations

  • Heart Centre at University LeipzigRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter tricuspid valve edge-to-edge repair

Arm Description

Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR.

Outcomes

Primary Outcome Measures

Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.

Secondary Outcome Measures

Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Change in dPdtmin
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Change in the early diastolic filling pattern as assessed by MRI.
All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner.

Full Information

First Posted
March 1, 2021
Last Updated
April 14, 2021
Sponsor
Heart Center Leipzig - University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04782908
Brief Title
Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
Acronym
HERACLES-HFpEF
Official Title
Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart Center Leipzig - University Hospital

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
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Tricuspid Regurgitation
Keywords
Heart failure with preserved ejection fraction, tricuspid regurgitation, transcatheter tricuspid valve edge-to-edge repair

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
Masking
None (Open Label)
Masking Description
Outcome assessors will be blinded whether they are analysing pre or post transcatheter tricuspid valve edge-to-edge repair data.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter tricuspid valve edge-to-edge repair
Arm Type
Experimental
Arm Description
Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR.
Intervention Type
Device
Intervention Name(s)
Transcatheter tricuspid valve edge-to-edge repair
Intervention Description
Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.
Primary Outcome Measure Information:
Title
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
Description
Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Time Frame
Periprocedural.
Secondary Outcome Measure Information:
Title
Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)
Description
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Time Frame
Periprocedural.
Title
Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.
Description
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Time Frame
Periprocedural.
Title
Change in dPdtmin
Description
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Time Frame
Periprocedural.
Title
Change in the early diastolic filling pattern as assessed by MRI.
Description
All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner.
Time Frame
Baseline and 1-month follow-up following TTVR.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team. Signs and symptoms of left-sided heart failure. Left-ventricular ejection fraction ≥50% Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure [PCWP] or left-ventricular end-diastolic pressure ≥15 mmHg) Exclusion Criteria: Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment Moderate aortic stenosis. Pregnancy Contraindication to perform cardiac magnetic resonance imaging. Conditions rendering patient unable to give informed consent to the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl-Patrik Kresoja, MD
Phone
0341865252596
Email
karl-patrik.kresoja@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Lurz, MD, PhD
Phone
0341865252529
Email
philipp.lurz@medizin.uni-leipzig.de
Facility Information:
Facility Name
Heart Centre at University Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl-Patrik Kresoja, MD
Phone
0341 865 252596
Email
karl-patrik.kresoja@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Philipp Lurz, MD, PhD
Phone
0341 865 252529
Email
philipp.lurz@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Karl-Philipp Rommel, MD
First Name & Middle Initial & Last Name & Degree
Christian Besler, MD
First Name & Middle Initial & Last Name & Degree
Matthias Unterhuber, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymized data will be made available on reasonable cooperation request.

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Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

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