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RecruitingNCT06309524HERITAGEUpdated Mar 13, 2024

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

An observational study in Tricuspid Regurgitation, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Istituto Auxologico Italiano · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tricuspid Regurgitation
03

In context

Tricuspid Valve Insufficiency

219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.

This study's planned enrollment of 17 is below the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.

Browse Tricuspid Valve Insufficiency studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (estimated)
Patient registry
No

Interventions

  • DeviceTricuspid transcatheter edge-to-edge repair

    Transcatheter tricuspid leaflets approximation

06

What researchers measure

Primary outcomes

  1. Inverse remodeling of right heart chambers

    Change in inverse remodeling of right heart chambers at 6 months after intervention

    Time frame: At baseline and at 6 months after intervention

  2. Heart failure hospitalization

    Incidence of heart failure hospitalization during 6 months after intervention

    Time frame: During 6 months after intervention

  3. Death

    Incidence of death during 6 months after intervention

    Time frame: During 6 months after intervention

07

Study locations

1 of 1 sites recruiting
  • Istituto Auxologico Italiano
    Milan, Lombardia 20149, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06309524
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 13, 2024
Start date
Feb 15, 2023
Primary completion
Jan 1, 2025 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Mar 13, 2024

Study contacts

Luca Grappiolo
Contact
luca.grappiolo@auxologico.it
+390261911 ext. 2894

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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