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New treatment option for Heart Failure With Severe Tricuspid Regurgitation
Official title TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure
ClinicalTrials.gov ID: NCT07442903
What this study is testing
- What it's testing
- Tricuspid regurgitation (TR) is a severe and highly prevalent disease that leads to right-sided heart failure. The severity of TR is associated with increasing morbidity and mortality.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Heart-failure NYHA class III despite optimal medical therapy
- Heart failure related hospitalization in the 12 month prior to Cordella PA pressure sensor system implant
- Planned tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR)
- Willingness to participate and sign informed consent
You likely can't join if
- Cardiogenic shock or hemodynamic instability
- Previous tricuspid intervention or surgery with repair or replacement of tricuspid leaflets
- Active endocarditis
- Tricuspid valve stenosis (baseline tricuspid valve in-flow gradient \> 5 mmHg)
- Life expectancy of less than 12 months
- Chronic renal failure requiring dialysis
See the full eligibility criteria
- Age ≥18 years
- Heart-failure NYHA class III despite optimal medical therapy
- Heart failure related hospitalization in the 12 month prior to Cordella PA pressure sensor system implant
- Planned tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR)
- Willingness to participate and sign informed consent
- Ability to perform PA pressure reading and telemonitoring
- Cardiogenic shock or hemodynamic instability
- Previous tricuspid intervention or surgery with repair or replacement of tricuspid leaflets
- Active endocarditis
- Tricuspid valve stenosis (baseline tricuspid valve in-flow gradient \> 5 mmHg)
- Life expectancy of less than 12 months
- Chronic renal failure requiring dialysis
- Anatomic conditions impeding implantation of PA sensor
- Acute pulmonary embolism or chronic thromboembolic pulmonary Hypertension (CTEPH)
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Germany
- München, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Germany; München, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.