An interventional study of transcatheter tricuspid valve intervention and PFO Control Cohort in Tricuspid Valve Regurgitation, sponsored by Heart and Diabetes Center North-Rhine Westfalia. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Heart and Diabetes Center North-Rhine Westfalia · Not applicable, Interventional, and Basic science
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Among 51 studies in Tricuspid Valve Insufficiency with a site in Germany — 24 open to participants now, 31 under way, none of them phase 3. Tricuspid Valve Insufficiency · Germany.
Among the 51 studies in Tricuspid Valve Insufficiency with a site in Germany, this one is the 7th largest by planned enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2025, is one of 23 with no phase, reaches primary completion later than 24 of the 30 other live ones, and was the 47th registered.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
Browse Tricuspid Valve Insufficiency studies →24 of the 51 studies in Tricuspid Valve Insufficiency with a site in Germany are open now. Recruiting first, the newest first:
Abbott Medical Devices · Sites in Germany, United States, France and 2 more countries
Ages 18+
LMU Klinikum · Sites in Germany
Ages 18+
Cardiovalve Ltd. · Sites in Germany
Ages 18–85
Robert Bosch Medical Center · Sites in Germany
Ages 18+
Medical University of Vienna · Sites in Germany, Austria, Italy and 1 more country
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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51 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 150 is above the median of 60 across 129 interventional studies indexed under Tricuspid Valve Insufficiency.
Median enrollment 60 across the 25 interventional studies, 506 across the 26 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
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23 of 51 have an industry lead sponsor. The 10 most frequent:
Heart and Diabetes Center North-Rhine Westfalia is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
Heart and Diabetes Center North-Rhine Westfalia has 4 studies filed under Tricuspid Valve Insufficiency — fewer than ten, so there is no comparison to draw.
6 of the studies in Tricuspid Valve Insufficiency with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05825898Ottawa Heart Institute Research CorporationOutcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment | 2026-12 |
| NCT07464106Robert Bosch Medical CenterEvaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults. | 2026-12 |
| NCT06212193Innoventric LTDInnoventric Trillium™ Stent Graft Early Feasibility Study (EFS) | 2026-12-20 |
| NCT05797519VDyne, Inc.Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation | 2026-12-30 |
| NCT07342036Hazem OmranProspective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion | 2027-01-01 |
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Among the 51 studies in Tricuspid Valve Insufficiency with a site in Germany, from their registry updates:
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Emerging evidence highlights a bidirectional gut-heart axis, particularly relevant in patients with right heart failure. Elevated right atrial pressures and systemic congestion may impair intestinal perfusion and compromise epithelial integrity, leading to increased gut permeability ("leaky gut") and translocation of microbial products. These processes can trigger systemic inflammation and exacerbate cardiac dysfunction. Alterations in the gut microbiome-collectively referred to as dysbiosis-have also been linked to heart failure pathogenesis. However, the role of intestinal barrier dysfunction and microbial signatures in patients with severe tricuspid regurgitation (TR) remains largely unexplored.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with functional tricuspid regurgitation (TR) who were evaluated for transcatheter tricuspid valve intervention
Exclusion Criteria:
Previous tricuspid valve repair or replacement
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with severe functional tricuspid regurgitation undergoing transcatheter tricuspid valve intervention (TTVI) as part of routine clinical care. The decision to perform TTVI is made independently of study participation. Patients undergo longitudinal assessment of gut microbial metabolites, intestinal permeability, and clinical parameters.
Procedure: transcatheter tricuspid valve intervention
relevant comorbidities or heart failure. The decision to perform PFO closure is made independently of study participation. This cohort serves as a reference group for the assessment of gut microbial metabolite profiles and intestinal permeability.
Procedure: PFO Control Cohort
transcatheter tricuspid valve intervention
Patent Foramen Ovale (PFO) Closure
Change in Gut Microbial Metabolite Plasma Levels
Change in plasma concentrations of gut microbial metabolites from baseline to 6 months after intervention, assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Time frame: Baseline (prior to intervention) and 6 months post-intervention (180 ± 14 days)
Change in Plasma Levels of Gut Microbial Metabolites at 30 Days
Changes in plasma concentrations of gut microbial metabolites from baseline to 30 days after intervention, quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Time frame: Baseline and 30 days post-intervention
Change in Intestinal Permeability at 6 Months
Changes in intestinal permeability from baseline to 6 months after intervention, assessed using a differential sugar absorption test with lactulose, rhamnose, and sucrose.
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Moderate-to-Severe or Severe Tricuspid Regurgitation at 30 Days
Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography.
Time frame: 30 days post-intervention
Moderate-to-Severe or Severe Tricuspid Regurgitation at 6 Months
Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography.
Time frame: 6 months post-intervention (180 ± 14 days)
All-Cause Mortality
Number of participants who die from any cause during the follow-up period.
Time frame: From intervention up to 6 months post-intervention
Heart Failure Rehospitalization
Number of participants experiencing at least one rehospitalization due to worsening heart failure during the follow-up period.
Time frame: From intervention up to 6 months post-intervention
Change in New York Heart Association (NYHA) Functional Class
Change in NYHA functional class from baseline to 6 months after intervention. NYHA functional class ranges from I (no limitation of physical activity) to IV (symptoms at rest). A lower class indicates better functional status.
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months after intervention. Scores range from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Levels
Change in serum NT-proBNP concentration from baseline to 6 months after intervention, assessed using laboratory blood analysis.
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Right Ventricular Basal Diameter
Change in right ventricular basal diameter from baseline to 6 months after intervention, assessed by transthoracic echocardiography. Measurements are expressed in millimeters (mm).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Right Ventricular Fractional Area Change (RV FAC)
Change in right ventricular fractional area change from baseline to 6 months after intervention, assessed by transthoracic echocardiography as a measure of right ventricular systolic function. Measurements are expressed as percentages (%).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Right Ventricular Global Longitudinal Strain (RV GLS)
Change in right ventricular global longitudinal strain from baseline to 6 months after intervention, assessed by transthoracic echocardiography using speckle-tracking analysis. Measurements are expressed as percentages (%).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Change in tricuspid annular plane systolic excursion from baseline to 6 months after intervention, assessed by transthoracic echocardiography as a measure of right ventricular longitudinal systolic function. Measurements are expressed in millimeters (mm).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Estimated Systolic Pulmonary Artery Pressure (sPAP)
Change in estimated systolic pulmonary artery pressure from baseline to 6 months after intervention, assessed by transthoracic echocardiography using the tricuspid regurgitation jet pressure gradient and estimated central venous pressure. Measurements are expressed in millimeters of mercury (mmHg).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular ejection fraction from baseline to 6 months after intervention, assessed by transthoracic echocardiography using the biplane Simpson method. Measurements are expressed as percentages (%).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Left Ventricular End-Systolic Volume (LVESV)
Change in left ventricular end-systolic volume from baseline to 6 months after intervention, assessed by transthoracic echocardiography. Measurements are expressed in milliliters (mL).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Change in Left Ventricular End-Diastolic Volume (LVEDV)
Change in left ventricular end-diastolic volume from baseline to 6 months after intervention, assessed by transthoracic echocardiography. Measurements are expressed in milliliters (mL).
Time frame: Baseline and 6 months post-intervention (180 ± 14 days)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jun 2029, 45 months after the start.
Of 86 interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Tricuspid Valve Insufficiency →
Heart and Diabetes Center North-Rhine Westfalia