Evaluation of the Innoventric Trillium™ Stent Graft for treating severe tricuspid regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is an early feasibility assessment of the Innoventric Trillium™ Stent Graft aimed at treating patients with severe or greater tricuspid regurgitation. It is a prospective, single-arm, multi-center study involving up to 15 patients across 10 sites in the US and 3 sites in Germany. Participants will undergo assessments at various intervals, including baseline, during the procedure, and at multiple follow-up points over five years to evaluate the safety and performance of the device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient has clinically significant TR graded as severe or greater
* Peak central venous pressure of ≥ 15mmHg
* Patient has NYHA functional classification of III or IV
* Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic

Exclusion Criteria:

Patients will be excluded from participation if ANY of the following criteria apply:

* Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.
* Anatomical suitability according to CT scan.
* Systolic Pulmonary Artery Pressure \> 65mmHg
* Moderate or more mitral valve stenosis
* Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
* Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
* Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
* Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
* Thrombocytopenia (Platelet count\< 80,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) within 14 days of the index procedure
* In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \< 12 months

Where it's running

• Cardiovascular Institute of Los Robles Health System
  Thousand Oaks, California, United States Recruiting
• Ascension St. John
  Detroit, Michigan, United States Recruiting
• Mayo Clinic Hospital (Rochester)
  Rochester, Minnesota, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting
• Stony Brook Heart Institute
  Stony Brook, New York, United States Recruiting
• The Christ Hospital
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Chen Lereya
• Email: chen@innoventric.com
• Phone: +972-52-8981783

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.