Clinical trials: Valve Heart Disease
Atrial Fibrillation, Atrial Flutter
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis
- Trial name
- SAFE-VEIN (NCT04632641)
- Testing
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events.
- Trial name
- NCT06926959
- Where
- 7 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Sun Yat-sen University
Tricuspid Valve Insufficiency
Transcatheter Interventions for Tricuspid Insufficiency in Italy
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment.
- Trial name
- TRIC-IT (NCT04735003)
- Testing
- Transcatheter tricuspid valve interventions
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Marianna Adamo
Mitral Valve Insufficiency
Determinants of the Progression and Outcome of Mitral Regurgitation
Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population.
- Trial name
- PROGRAM (NCT01835054)
- Testing
- Blood biomarkers, DNA collection, Echocardiography
- Where
- 4 sites in Belgium, Canada and 1 more
- Volunteers
- 440 people
- Sponsor
- Laval University
Aortic Valve Disease
Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation…
- Trial name
- NCT05389631
- Testing
- no intervention
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Helios Health Institute GmbH
Severe Aortic Stenosis
Act on Quality of Life in Patients With aortIc Stenosis
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions.
- Trial name
- ALPINIST (NCT06477042)
- Testing
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
- Where
- 4 sites in France
- Volunteers
- 240 people
- Sponsor
- Hospices Civils de Lyon
Tricuspid Valve Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid…
- Trial name
- TriCLASP (NCT04614402)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System
- Where
- 15 sites in Germany, Greece and 2 more
- Volunteers
- 300 people
- Sponsor
- Edwards Lifesciences
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
Coronary Artery Disease, Aortic Stenosis, Severe
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI…
- Trial name
- IMPACTavi (NCT04976062)
- Testing
- Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 150 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Obstructive Hypertrophic Cardiomyopathy
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.
- Trial name
- COMPASS-HCM (NCT06551129)
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Bristol-Myers Squibb
Mitral Valve Stenosis
Three Dimensional Versus Two Dimensional Echocardiography in Assessment of Severity and Scoring of Rheumatic Mitral Stenosis.
Although the prevalence of rheumatic fever is decreasing in developed countries, it still affects numerous areas in the non- industrialized world.
- Trial name
- NCT04968431
- Testing
- 2D Echocardiography, 3D Echocardiography
- Volunteers
- 60 people
- Sponsor
- Assiut University
Aortic Valve Regurgitation
Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation
The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with…
- Trial name
- ELEANOR (NCT05438862)
- Testing
- State of art aortic valve surgery
- Where
- 8 sites in Belgium, Czechia and 1 more
- Volunteers
- 217 people
- Sponsor
- Na Homolce Hospital
Valvular Heart Disease, Rheumatic Heart Disease
Echocardiographic Screening of Pregnant Women During Antenatal Care
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings.
- Conditions
- Valvular Heart Disease, Rheumatic Heart Disease, Pregnancy Complications
- Trial name
- NCT04936815
- Testing
- Transthoracic echocardiography
- Where
- 2 sites in Nepal, Switzerland
- Volunteers
- 9,000 people
- Sponsor
- Thomas Pilgrim
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Cardiac Valve Disease
Preoperative Optimization of Cardiac Valve Patients' Expectations
Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety.
- Trial name
- ValvEx (NCT04502121)
- Testing
- EXPECT: Preoperative optimization of cardiac valve patient's expectations
- Where
- Germany
- Volunteers
- 89 people
- Sponsor
- Philipps University Marburg
Heart Failure, Mitral Regurgitation
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following…
- Trial name
- NCT04729933
- Testing
- V-Wave Shunt Placement
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- samir kapadia
Hypertrophic Cardiomyopathy
Biventricular Pacing in Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in…
- Trial name
- NCT00504647
- Testing
- Biventricular Pacemaker
- Where
- 3 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- University Hospital Birmingham
Anti-coagulation Therapy, DVT
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to…
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple
- Trial name
- WARFARIN (NCT01305148)
- Testing
- Warfarin GenoSTAT Test
- Where
- 56 sites in United States
- Volunteers
- 3,800 people
- Sponsor
- Iverson Genetic Diagnostics, Inc.
Tricuspid Regurgitation, Right Heart Failure
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients.
- Conditions
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial
- Trial name
- NCT05179616
- Testing
- Transcatheter edge-to-edge tricuspid valve repair
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Helios Klinikum Pforzheim