Clinical trials: Valve
Valvular Heart Disease
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the…
- Trial name
- PREVUE-VALVE (NCT05357404)
- Where
- United States
- Volunteers
- 2,870 people, healthy volunteers welcome
- Sponsor
- Cardiovascular Research Foundation, New York
Non-valvular Atrial Fibrillation (NVAF)
A Study to Learn Whether There Are Differences in the Kidney's Ability to Work Properly in Korean Patients With Non-valvular Atrial Fibrillation (Irregular and Often Rapid Heartbeat Not Caused by a Heart Valve Problem) Treated With Rivaroxaban as Compared to Those Treated With Warfarin
This is an observational study in which data collected from the past of patients with non-valvular atrial fibrillation (NVAF) is studied.
- Trial name
- RENOVATOR (NCT05022758)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- South Korea
- Volunteers
- 45,000 people
- Sponsor
- Bayer
Aortic Stenosis
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with…
- Trial name
- SOLVE-TAVI (NCT02737150)
- Testing
- CoreValve Evolut R, Edwards Sapien 3, Local anesthesia with conscious sedation
- Where
- Germany
- Volunteers
- 444 people
- Sponsor
- Helios Health Institute GmbH
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Pregnancy, Anticoagulation
Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
The ability to diagnose and surgically repair poorly functioning heart valves has yielded a significant population of women that are of childbearing age with mechanical/ bioprosthetic heart valves.
- Conditions
- Pregnancy, Anticoagulation, Prosthetic Heart Valves
- Trial name
- NCT00329290
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Irvine
Aortic Valve Disease
DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.
- Trial name
- DIAMOND (NCT05687448)
- Testing
- Apixaban 5 MG Oral Tablet, Aspirin 75 to 100mg once a day
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Mitral Regurgitation
Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?
Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy.
- Trial name
- NCT05836376
- Testing
- Mitral valve annuloplasty
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Michele De Bonis
Anesthesia
Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: RCT
Several studies demonstrated the effectiveness of OFA in patients undergoing non-cardiac surgery. Preoperative use of Cox inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively .
- Trial name
- NCT04648540
- Testing
- Dexmedetomidine 0.5 mic/kg/h, Fentanyl 1 mic/kg/hr
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cairo University
Coronary Artery Disease
Impact of Patient-Prosthesis-Mismatch on Coronary Flow Reserve
Complete normalization of CFR following AVR for aortic stenosis was observed only for stentless valves. Besides the superior hemodynamic performance this might explain the excellent long term results of this valve design.
- Trial name
- NCT00310947
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Trial name
- NCT07033455
- Testing
- HRS-1893
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten in Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US
- Trial name
- NCT07168655
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 163 people
- Sponsor
- Bristol-Myers Squibb
Incidence of Junctional Rhythm
Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.
Transcatheter Aortic Valve Implantation (TAVI) aims to treat patients with symptomatic narrowing of the aorta by implanting an aortic bioprosthesis.
- Trial name
- JUNCTAVI (NCT06599008)
- Where
- 2 sites in France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Clermont-Ferrand
Heart Valve Diseases, Aortic Valve Stenosis
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions.
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT07068633
- Where
- 2 sites in South Korea
- Volunteers
- 30,000 people
- Sponsor
- Yonsei University
Lymphatic Insufficiency, Heart Failure
Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation
The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.
- Conditions
- Lymphatic Insufficiency, Heart Failure, Edema
- Trial name
- LYMTRIVA (NCT04595448)
- Where
- Denmark
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Aortic Valve Stenosis
Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.
- Trial name
- NCT01475799
- Testing
- Replacement of the Aortic Stenotic Valve
- Where
- 12 sites in France, Germany and 3 more
- Volunteers
- 112 people
- Sponsor
- Direct Flow Medical, Inc.
Hypertrophic Cardiomyopathy
Paced Dyssynchrony and Myocardial Perfusion IN apiCal Hcm
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease. A relatively common subgroup of HCM patients have apical HCM - a type of heart muscle disease that causes abnormal muscle thickening towards the tip…
- Trial name
- PINCHcm (NCT04231032)
- Testing
- Asynchronous dual chamber pacing (DOO) with paced ventricular activation, Asynchronous atrial pacing (AOO) with intrinsic ventricular activation
- Where
- United Kingdom
- Volunteers
- 11 people
- Sponsor
- Barts & The London NHS Trust
Aortic Valve Replacement, Coronary Artery Bypass Grafting
Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position
The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic…
- Trial name
- NCT00477555
- Testing
- Aortic implantation of Mosaic Ultra porcine bioprosthesis
- Where
- 11 sites in Austria, Belgium and 3 more
- Volunteers
- 43 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
Regression of Myocardial Fibrosis After Aortic Valve Replacement
Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and the Western world. Surgery for severe AS prior to symptom onset is controversial.
- Trial name
- RELIEF-AS (NCT02174471)
- Where
- United Kingdom
- Volunteers
- 181 people
- Sponsor
- University College, London
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
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