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

NCT06309524 | Recruiting FDA Device

• 1 other identifier: 09C332
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (3)

• 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

• Heart failure hospitalization

  Incidence of heart failure hospitalization during 6 months after intervention

  During 6 months after intervention

• Death

  Incidence of death during 6 months after intervention

  During 6 months after intervention

Interventions

Tricuspid transcatheter edge-to-edge repair DEVICE

Transcatheter tricuspid leaflets approximation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic tricuspid regurgitation that fulfill Guidelines criteria for transcatheter tricuspid valve repair

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, Lombardy, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Luca Grappiolo

CONTACT

+390261911; luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: February 15, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)