Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT04559256
Eligibility Criteria:
Inclusion Criteria:
* Chronic tricuspid regurgitation 2+ to 4+ on a scale of 4+ (moderate to severe) with annular diameter ≥ 40 mm with valve systolic pulmonary pressure (sPAP) ≤ 60 mmHg
* New York Heart Association (NYHA) Class II-IV
* Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
* Left ventricular ejection fraction ≥ 30%
* Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
* The local site Heart Team concur that surgery will not be offered as a treatment option
* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
* Inability to perform cardiopulmonary exercise test
* Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
* Previous tricuspid valve repair or replacement
* Severe precapillary pulmonary hypertension (PVR\>6 WE)
* Cerebrovascular accident (CVA) within the past 6 months
* Presence of trans-tricuspid pacemaker or defibrillator leads which cause impingement of the tricuspid valve leaflet as evaluated by echocardiography
* Subject is on chronic dialysis and/or anemia (Hb \< 9 g/L)
* Myocardial infarction or known unstable angina within 30 days prior to the index procedure
* Any percutaneous coronary intervention or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure
* Previous tricuspid valve repair or replacement
* Life expectancy of less than 12 months
* Patients with cardiac cachexia
* Echocardiographic evaluation not available or not suitable for analysis at baseline
* Unsuitable anatomy for transcatheter tricuspid intervention
* Key information from patients (e.g. NYHA, TR grade) not available
* Known allergy or intolerance against the studied device
* Persons held in an institution by legal or official order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04559256
Study Brief:
Protocol Section:
NCT04559256