Clinical trials: Heart Disease, Valvular
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Non-valvular Atrial Fibrillation (AF)
Vortosiran in Atrial Fibrillation
This is a randomised, actively controlled Phase IIb trial to evaluate the safety and pharmacodynamics (PD) of two blinded doses of subcutaneously administered vortosiran and open-label apixaban in patients with AF.
- Trial name
- NCT07870889
- Testing
- Vortosiran, Apixaban
- Where
- 15 sites in Denmark, Norway and 2 more
- Volunteers
- 150 people
- Sponsor
- Ribocure Pharmaceuticals AB
Atrial Fibrillation
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention…
- Trial name
- SAFARI (NCT01805531)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- France
- Volunteers
- 411 people
- Sponsor
- Bayer
Moderate Aortic Valve Stenosis
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
- Trial name
- KATALYST-AV (NCT07001800)
- Testing
- Ataciguat
- Where
- 74 sites in United States, Canada
- Volunteers
- 1,276 people
- Sponsor
- Kardigan, Inc.
Tricuspid Valve Regurgitation
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and…
- Trial name
- NCT02471807
- Testing
- Edwards FORMA Tricuspid Transcatheter Repair System
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Parkinson Disease
Observational Study of Pergolide Mesylate and Cardiac Valvulopathy
The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line…
- Trial name
- NCT00311532
- Where
- 14 sites in Belgium, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Atrial Fibrillation
Anticoagulation Preference by AF Patients Study
The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin…
- Trial name
- PRiSMA-AF (NCT02607371)
- Testing
- VKAs, NOACs including Rivaroxaban (Xarelto, BAY59-7939), Edoxaban
- Where
- Switzerland
- Volunteers
- 198 people
- Sponsor
- Bayer
Atrial Fibrillation
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
- Trial name
- NCT01896297
- Testing
- Pradaxa, dabigatran etexilate
- Where
- 26 sites in United States
- Volunteers
- 63 people
- Sponsor
- Boehringer Ingelheim
Mitral Regurgitation, Heart Failure
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
- Trial name
- PTOLEMY2Canada (NCT00815386)
- Testing
- Percutaneous transvenous mitral annuloplasty
- Where
- 3 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Viacor
Aortic Valve Disease
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15…
- Trial name
- NCT03924661
- Testing
- Aortic Valve Replacement
- Where
- 13 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
Navitor Japan Study
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
- Trial name
- NCT07193888
- Testing
- Navitor Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis Symptomatic
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic…
- Trial name
- NCT06680427
- Testing
- Siegel Transcatheter Aortic Valve (TAVR)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- MiRus
Mitral Regurgitation
A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
A prospective, open-label, and multi-centered feasibility registry.
- Trial name
- VELOCITY (NCT02858245)
- Testing
- No intervention - registry
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI)…
- Trial name
- NCT01721642
- Testing
- Apica Cardiovascular ASC Access, Stability and Closure Device
- Volunteers
- 31 people
- Sponsor
- Apica Cardiovascular Limited
Pulmonary Regurgitation
Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.
- Trial name
- NCT02846753
- Testing
- trans catheter heart valve replacement
- Volunteers
- 84 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe…
- Trial name
- TRI-SUCCESS (NCT07919366)
- Testing
- Innoventric Unica™ System
- Volunteers
- 510 people
- Sponsor
- Innoventric LTD
Heart Valve Diseases
Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm
The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of…
- Trial name
- NCT01156272
- Testing
- ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm
- Where
- Canada
- Sponsor
- Medtronic Cardiovascular
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.
Mitral Regurgitation (MR)
Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data…
- Trial name
- METRIX (NCT07413926)
- Testing
- Chord-X system implant
- Where
- 4 sites in United States, Italy and 1 more
- Volunteers
- 110 people
- Sponsor
- Artivion Inc.
Severe Aortic Valve Stenosis
The PROTEMBO Trial
The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and…
- Trial name
- NCT05873816
- Testing
- ProtEmbo - Cerebral Embolic Protection, Sentinel - Cerebral Embolic Protection
- Where
- 20 sites in United States, Germany and 1 more
- Volunteers
- 284 people
- Sponsor
- Protembis GmbH