Clinical trials: Regurgitation
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 38 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Atrial Functional, Mitral Regurgitation (MR)
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial functional mitral regurgitation (AFMR) develops when enlargement and remodeling of the left atrium and mitral annulus prevent the mitral valve leaflets from closing completely, allowing blood to leak backward through the…
- Trial name
- PRECISE-AFMR I (NCT07741253)
- Testing
- Transcatheter Edge-to-Edge Repair
- Where
- China
- Volunteers
- 182 people
- Sponsor
- China National Center for Cardiovascular Diseases
Mitral Regurgitation Functional, Mitral Valve Disease
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
- Conditions
- Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases
- Trial name
- NCT04147884
- Testing
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Where
- 4 sites in United States, Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients.
- Trial name
- FIM-TRICSTER (NCT07536724)
- Testing
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Where
- 2 sites in Uzbekistan
- Volunteers
- 10 people
- Sponsor
- Medira GmbH
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
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
EFS of the DUO System for Tricuspid Regurgitation
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- TANDEM II (NCT05913908)
- Testing
- DUO Transcatheter Tricuspid Coaptation Valve System
- Where
- 18 sites in United States, Poland
- Volunteers
- 15 people
- Sponsor
- CroiValve Limited
Mitral Regurgitation
Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
This study looks at a heart procedure called transcatheter mitral valve replacement. Doctors use a device called SAPIEN M3 to replace a damaged heart valve.
- Trial name
- DGS-M3 (NCT07878195)
- Where
- Austria
- Volunteers
- 77 people
- Sponsor
- Medical University of Vienna
Mitral Regurgitation
The PALMETTO Study
Prospective, single-arm, multicenter, non-randomized early feasibility study
- Trial name
- PALMETTO (NCT07885839)
- Testing
- ReValve System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- ReValve Solutions Inc.
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Isolated Aortic Stenosis, Mitral Regurgitation
A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease
The purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence (computer information), will show similar abnormalities to an echocardiogram or cardiac…
- Trial name
- NCT04960280
- Testing
- ©VoqX stethoscope
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Mayo Clinic
Aortic Root Aneurysm, Aortic Regurgitation
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six…
- Trial name
- AORTLANTIC (NCT05515848)
- Testing
- No intervention
- Where
- 5 sites in France
- Volunteers
- 529 people
- Sponsor
- Nantes University Hospital
Mitral Regurgitation, ATTR-Cardiomyopathy
Edge-to-edge Mitral Valve Repair in ATTR-CM
No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient…
- Conditions
- Mitral Regurgitation, ATTR-Cardiomyopathy, Edge-to-Edge Mitral Valve Repair
- Trial name
- MILLENNIAL (NCT06075823)
- Testing
- TEER, Optimal Medical Therapy
- Where
- 10 sites in Austria, Germany and 1 more
- Volunteers
- 106 people
- Sponsor
- Medical University of Vienna
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- Trial name
- NCT07140562
- Testing
- Tricuspid Annular Therapy System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- Tangent Cardiovascular Inc.
Tricuspid Valve Disease, Heart Valve Diseases
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
- Conditions
- Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
- Trial name
- TRICAV-II (NCT06458907)
- Testing
- TricValve System, Optimal medical therapy
- Where
- 34 sites in United States
- Volunteers
- 780 people
- Sponsor
- P+F Products + Features USA Inc.
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Prospective Evaluation of AI-ECG for SHD Detection
AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing…
- Conditions
- Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- Trial name
- AI-ECG-SHD (NCT07057466)
- Testing
- Traditional 12-lead Electrocardiogram, Apple Watch Series 4 Single-lead Electrocardiogram, Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram
- Where
- 6 sites in United Kingdom
- Volunteers
- 590 people
- Sponsor
- Imperial College London
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Valve Insufficiency
The ENCIRCLE Trial
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are…
- Trial name
- ENCIRCLE (NCT04153292)
- Testing
- SAPIEN M3 valve and dock
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 786 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation (TR)
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved…
- Trial name
- TREAT TR (NCT07586995)
- Testing
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR CED Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences