Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

Congestive Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782908
• Other study ID #: HERACLES-HFpEF
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: Heart Center Leipzig - University Hospital
• Contact: Karl-Patrik Kresoja, MD
• Phone: 0341865252596
• Email: karl-patrik.kresoja[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Transcatheter tricuspid valve edge-to-edge repair
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.

Locations

Country	Name	City	State
Germany	Heart Centre at University Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Periprocedural.
Secondary	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.	Periprocedural.
Secondary	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.	Periprocedural.
Secondary	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.	Periprocedural.
Secondary	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.	Baseline and 1-month follow-up following TTVR.