Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair

Tricuspid Regurgitation Clinical Trial

— HERITAGE  

Official title:

Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge Dell'Insufficienza Tricuspidale Severa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309524
• Other study ID #: 09C332
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Luca Grappiolo
• Phone: +390261911
• Email: luca.grappiolo[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age> 18 years
• Severe STR, amenable to percutaneous treatment with T-TEER
• Acceptance to be part of this study by signing the informed consent
• Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps
• Availability for clinical, CCT and, echocardiography follow-up visits

Exclusion Criteria:

• Pregnancy
• Severe chronic kidney disease (GFR <30 mL/min)
• Hypersensitivity reactions to contrast media
• Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
• Bad acoustic window with inadequate echocardiographic images.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Tricuspid transcatheter edge-to-edge repair
Transcatheter tricuspid leaflets approximation

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inverse remodeling of right heart chambers	Change in inverse remodeling of right heart chambers at 6 months after intervention	At baseline and at 6 months after intervention
Primary	Heart failure hospitalization	Incidence of heart failure hospitalization during 6 months after intervention	During 6 months after intervention
Primary	Death	Incidence of death during 6 months after intervention	During 6 months after intervention