Clinical trials: Severe Heart Valve Disease
Tricuspid Valve Regurgitation, Tricuspid Valve Disease
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases
- Trial name
- TRIVITA (NCT07516444)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Where
- United States
- Volunteers
- 730 people
- Sponsor
- VDyne, Inc.
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Transcatheter Aortic Valve Implantation
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months.
- Trial name
- EMPIRE-II (NCT05804903)
- Testing
- (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 7 sites in Finland, Germany and 3 more
- Volunteers
- 177 people
- Sponsor
- NVT GmbH
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the…
- Trial name
- NCT05417945
- Testing
- JensClip transcatheter valve repair system
- Volunteers
- 124 people
- Sponsor
- Jenscare Scientific
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Insufficiency
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Study to evaluate the safety and performance of the Twelve TMVR System
- Trial name
- NCT02428010
- Testing
- TMVR Implant
- Where
- Poland
- Volunteers
- 3 people
- Sponsor
- Medtronic Cardiovascular
Severe Pulmonary Valve Regurgitation
Harmony TPV EMEA PMS
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as…
- Trial name
- NCT06906926
- Testing
- Certain imaging assessments can be non-Standard of Care
- Where
- 12 sites in Denmark, France and 6 more
- Volunteers
- 80 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII S3HR/NR7 (NCT03222141)
- Testing
- TAVR Implantation of the THV Prosthesis
- Where
- 40 sites in United States, Canada
- Volunteers
- 583 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic…
- Trial name
- PII S3i (NCT03222128)
- Testing
- TAVR
- Where
- 51 sites in United States
- Volunteers
- 1,074 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
- Trial name
- NCT04703699
- Testing
- Myval Transcatheter Heart Valve Series
- Where
- 8 sites in Estonia, Italy and 5 more
- Volunteers
- 200 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid…
- Conditions
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD)
- Trial name
- TRIUMPH (NCT07687485)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
- Where
- 2 sites in United States
- Volunteers
- 700 people
- Sponsor
- Laplace Interventional, Inc
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
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