Clinical trials: Valve Regurgitation, Tricuspid
Tricuspid Regurgitation
The TRICURE First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver…
- Trial name
- TRICURE (NCT05126030)
- Testing
- Topaz TTVR System
- Where
- 11 sites in Belgium, France
- Volunteers
- 20 people
- Sponsor
- TRiCares
Severe Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
- Trial name
- PATHFINDER (NCT07321899)
- Testing
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Where
- 13 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Valve Regurgitation
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
- Trial name
- bRIGHT (NCT04483089)
- Testing
- Transcatheter heart valve procedure
- Where
- 25 sites in Austria, Denmark and 6 more
- Volunteers
- 511 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)
The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.
- Trial name
- NCT04936802
- Testing
- Transcatheter tricuspid valve repair system (Trialign)
- Volunteers
- 5 people
- Sponsor
- Xijing Hospital
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation, Heart Failure
The Long-term Course of Moderate Tricuspid Regurgitation
To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.
- Conditions
- Tricuspid Regurgitation, Heart Failure, Echocardiography
- Trial name
- LOCOMOTRI (NCT06169345)
- Testing
- Echocardiographic evaluation
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- IRCCS San Raffaele
Tricuspid Valve Insufficiency
MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair
The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness.
- Trial name
- NCT03166488
- Testing
- MRI
- Sponsor
- Mayo Clinic
Tricuspid Regurgitation
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage.
- Trial name
- NCT04339192
- Testing
- Minimally Invasive Tricuspid Surgery
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Shanghai Zhongshan Hospital
Tricuspid Regurgitation, Heart Failure
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
The goal of this observational study is to characterize the population of patients qualified for transcatheter tricuspid valve interventions (TTVI).
- Conditions
- Tricuspid Regurgitation, Heart Failure, Valve Heart Disease
- Trial name
- CAPTURE (NCT06838611)
- Testing
- Transcatheter edge-to-edge repair
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- Medical University of Warsaw
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
Tricuspid Valve Regurgitation
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- TRIBUTE (NCT05767645)
- Testing
- Mistral Procedure
- Where
- Israel
- Volunteers
- 75 people
- Sponsor
- Mitralix
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk…
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- CLASP II TR (NCT04097145)
- Testing
- Edwards PASCAL System, Optimal Medical Therapy
- Where
- 79 sites in United States, Canada
- Volunteers
- 1,270 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation, Heart Failure
Structural Heart and Valve Network PROSPECTIVE Registry
Background: Treatments for structural heart and valve disease are quickly changing. But treatment could be improved. Researchers want to gather data from people with this disease.
- Conditions
- Mitral Valve Regurgitation, Heart Failure, Heart Valve Disease, Tricuspid Valve Regurgitation
- Trial name
- NCT03928639
- Where
- United States
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Insufficiency, Aortic Stenosis
Automated Phonocardiography Analysis in Adults
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers…
- Conditions
- Aortic Insufficiency, Aortic Stenosis, Mitral Insufficiency, Mitral Insufficiency and Aortic Stenosis
- Trial name
- NCT03600051
- Testing
- Automated Heart Murmur Detection AI
- Where
- Austria
- Volunteers
- 90 people
- Sponsor
- CSD Labs GmbH
Tricuspid Regurgitation (TR)
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment.
- Trial name
- NCT06568003
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Jenscare Innovation Inc.
Tricuspid Regurgitation, Heart Failure
Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to…
- Trial name
- NCT04570098
- Where
- Germany
- Volunteers
- 1,016 people
- Sponsor
- Charite University, Berlin, Germany
Tricuspid Regurgitation
PASCAL for Tricuspid Regurgitation - a European Registry
This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in…
- Trial name
- PASTE (NCT05328284)
- Testing
- PASCAL leaflet repair system
- Where
- 14 sites in Germany, Sweden and 1 more
- Volunteers
- 1,000 people
- Sponsor
- LMU Klinikum
Tricuspid Regurgitation, Heart Failure
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter…
- Conditions
- Tricuspid Regurgitation, Heart Failure, Structural Heart Disease, Interventional Cardiology
- Trial name
- TTVR-AHI (NCT06954792)
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Columbia University
Ischemic Heart Disease, Aortic Stenosis, Severe
Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass.
- Conditions
- Ischemic Heart Disease, Aortic Stenosis, Severe, Aortic Insufficiency, Mitral Stenosis
- Trial name
- NCT06377449
- Testing
- Ultrasound examination of the lungs
- Where
- Russia
- Volunteers
- 186 people
- Sponsor
- Saint Petersburg State University, Russia
Tricuspid Regurgitation (TR)
The TRICURE US IDE Pivotal Study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
- Trial name
- TRICURE US IDE (NCT07528326)
- Testing
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Where
- United States
- Volunteers
- 831 people
- Sponsor
- TRiCares