Clinical trials: Heart Disease, Valvular
Mitral Regurgitation
A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice.
- Trial name
- PREMISE (NCT03592043)
- Testing
- MitraClip
- Where
- Canada
- Volunteers
- 1,191 people
- Sponsor
- Population Health Research Institute
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
Aortic Valve Insufficiency, Aortic Valve Stenosis
Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight
The National Space Biomedical Research Institute is interested in learning more about heart function in space. One potential problem with long duration, manned space flight is muscle loss- including loss of heart muscle.
- Trial name
- NCT00598598
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- The Cleveland Clinic
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Amyloidosis Cardiac, Aortic Stenosis, Severe
Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree.
- Trial name
- CAUSATIVE (NCT06066632)
- Where
- Italy
- Volunteers
- 480 people
- Sponsor
- University Hospital of Ferrara
Hypertrophic Cardiomyopathy
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy
Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.
- Trial name
- PRIMARy (NCT02994615)
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Hypertrophic Cardiomyopathy, Genetic Disease
Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy
Investigators aim to use comparative exome and/or genome sequencing to discover causative molecular lesions for phenotypes hypothesized to be caused by somatic mutations.
- Conditions
- Hypertrophic Cardiomyopathy, Genetic Disease, Gene Product Sequence Variation
- Trial name
- NCT03043209
- Testing
- Genomic sequencing
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation
This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe…
- Trial name
- TANDEM I (NCT05296148)
- Testing
- Transcatheter Tricuspid Valve Implantation
- Where
- 3 sites in Poland
- Volunteers
- 10 people
- Sponsor
- CroiValve Limited
Type II Diabetes
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
- Trial name
- DIAPASON (NCT01862237)
- Testing
- Intervention
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Hospices Civils de Lyon
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Severe Aortic Stenosis
CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it…
- Trial name
- CLEAR-AS (NCT07469371)
- Testing
- CCTA plus CT-FFR-informed preoperative decision strategy, CCTA-guided preoperative decision strategy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Aortic Stenosis, Heart Block
Conduction Disease After Transcatheter Aortic Valve Replacement
This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust…
- Conditions
- Aortic Stenosis, Heart Block, Aortic Insufficiency
- Trial name
- NCT04489095
- Testing
- Electrophysiology Study
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- Henry Ford Health System
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
Mitral Regurgitation
Comparison of Transcatheter Edge-to-edge Repair Using Echo Only with Echo Combined with X Ray for Mitral Regurgitation (ECHO-CLIP)
Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated.
- Trial name
- NCT06684171
- Testing
- Echocardiographic guidance, Fluoroscopic guidance
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Pan Xiangbin
Aortic Stenosis
Promoting Shared Decision Making for Severe Aortic Stenosis
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: Do patient decision aids and clinician skills training course…
- Trial name
- IMPACT SDM (NCT06171737)
- Testing
- Decision Aid, Shared Decision Making Skills Training
- Where
- 8 sites in United States
- Volunteers
- 1,300 people
- Sponsor
- Massachusetts General Hospital
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid…
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT-II (NCT03225612)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in Germany, Italy and 2 more
- Volunteers
- 60 people
- Sponsor
- Mitralign, Inc.