Clinical trials: Cardiac Valve Disease
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Real-World Effectiveness of Mavacamten in Canada
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM)…
- Trial name
- MAVEN (NCT06338202)
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- Bristol-Myers Squibb
Cardiac Arrythmias, Unstable Angina
CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG
This is a prospective, controlled, comparative clinical trial of a new ECG monitoring system CardioSenseSystem prior CE marking.
- Conditions
- Cardiac Arrythmias, Unstable Angina, Heart Valve Disorders, Disorder of Aorta
- Trial name
- NCT03610529
- Testing
- CardioSenseSystem, Philips Intellivue
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Novosense AB
Severe Tricuspid Regurgitation
TRICUS STUDY - Safety and Efficacy of the TricValve® Device
The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk…
- Trial name
- NCT03723239
- Testing
- TricValve® System
- Where
- Lithuania
- Volunteers
- 9 people
- Sponsor
- P+F Products + Features GmbH
Mitral Valve Stenosis, Atrial Fibrillation
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin
Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population.
- Trial name
- NCT03673605
- Testing
- Rivaroxaban 15 mg, Warfarin
- Where
- Pakistan
- Sponsor
- PharmEvo Pvt Ltd
Tricuspid Regurgitation
A First in Human Study for the Versa Device for Tricuspid Regurgitation
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical…
- Trial name
- NCT06368401
- Testing
- Versa Implant
- Where
- 5 sites in Brazil, Chile and 1 more
- Volunteers
- 10 people
- Sponsor
- Versa Vascular, Inc
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
An Observational, Prospective Evaluation of the Trifecta™ Valve
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional…
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00727181
- Testing
- Trifecta aortic heart valve
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Symptomatic Functional MR 3 or Greater
AMEND TS Early Feasibility Study
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation.
- Trial name
- NCT06951672
- Testing
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Valcare Medical Ltd.
Aortic Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk…
- Trial name
- NCT02207569
- Testing
- CoreValve Evolut R TAVR system
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Cardiovascular
Diseases of Mitral and Aortic Valves
Cingularbio® Heart Valve Clincial Study
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
- Trial name
- NCT02755220
- Testing
- Cingularbio® Aortic valve replacement
- Where
- 5 sites in Belgium, China and 1 more
- Volunteers
- 197 people
- Sponsor
- Shanghai Cingularbio Co. Ltd
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
Left Ventricular Dysfunction, Right Ventricular Dysfunction
A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine…
- Conditions
- Left Ventricular Dysfunction, Right Ventricular Dysfunction, Pulmonary Hypertension, Heart Valve Diseases
- Trial name
- NCT01076296
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- GE Healthcare
Aortic Valve Disease
Avalus Ultra Post-Approval Study (PAS)
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
- Trial name
- NCT06506903
- Testing
- Medtronic Avalus Ultra
- Where
- 15 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medtronic Cardiac Surgery
Symptomatic Severe Aortic Stenosis
Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Evaluation of TAVR using the NAVITOR valve in a Global Investigation.
- Trial name
- VANTAGE (NCT04788888)
- Testing
- Navitor Transcatheter Aortic valve and FlexNav Delivery system
- Where
- 37 sites in Australia, Austria and 9 more
- Volunteers
- 434 people
- Sponsor
- Abbott Medical Devices
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
Obstructive Hypertrophic Cardiomyopathy
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM).
- Trial name
- CAMELLIA-HCM (NCT07023341)
- Testing
- BAY3723113
- Where
- 23 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Bayer
Aortic Regurgitation
HAART Model 300 Annuloplasty Ring
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D…
- Trial name
- NCT01400841
- Testing
- HAART 300 Annuloplasty Device
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 18 people
- Sponsor
- Biostable Science & Engineering
Thromboembolism, Heart Valve Prosthesis
Follow on Study From RE-ALIGN
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
- Trial name
- NCT01505881
- Testing
- dabigatran etexilate low dose, warfarin 5mg, dabigatran etexilate intermediate dose
- Where
- 30 sites in Belgium, Canada and 7 more
- Volunteers
- 158 people
- Sponsor
- Boehringer Ingelheim
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
CoreValve® System Australia/New Zealand Clinical Study
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk
- Trial name
- NCT01015612
- Testing
- Medtronic CoreValve® System
- Where
- 10 sites in Australia, New Zealand
- Volunteers
- 634 people
- Sponsor
- Medtronic Cardiovascular
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy