Clinical trials: Aortic Valve Disease
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Aortic Valve Stenosis
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis.
- Trial name
- NCT04103931
- Testing
- "Treatment Choices for Aortic Stenosis" Decision Aid
- Where
- 2 sites in United States
- Volunteers
- 67 people
- Sponsor
- Massachusetts General Hospital
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
Anesthesia, Analgesia
Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI)
Hemodynamic stability is the main goal of the anesthetic method during Transcatheter Aortic Valve Implantation (TAVI). Pain during the procedure may cause patients to move therefore hemodynamic instability.
- Conditions
- Anesthesia, Analgesia, Block, Aortic Valve Stenosis
- Trial name
- NCT06762288
- Testing
- Ultrasound, Local anesthesia and sedation
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Istanbul University - Cerrahpasa
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 Valve Stenosis
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
To evaluate the long-term results after transcatheter aortic valve replacement
- Trial name
- CSI-TAVR (NCT02162069)
- Testing
- CE certified transcatheter ( aortic valve replacement)
- Where
- Germany
- Volunteers
- 843 people
- Sponsor
- University of Ulm
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
- Conditions
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Trial name
- BRAVO 2/3 (NCT01651780)
- Testing
- Bivalirudin, Unfractionated Heparin
- Where
- 33 sites in Canada, France and 5 more
- Volunteers
- 803 people
- Sponsor
- The Medicines Company
Cardiovascular Disease, Aortic Dissection
Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
XueBiJing, a Chinese herbal derived therapeutic, has been approved to treat severe infections (sepsis) in critically ill patients (China Food and Drug Administration; Beijing, China, Number Z20040033).
- Conditions
- Cardiovascular Disease, Aortic Dissection, Coronary Artery Disease, Valve Heart Disease
- Trial name
- NCT04993794
- Testing
- XueBiJing Injection, Normal saline
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Nanjing Medical University
Amyloidosis, Aortic Valve Stenosis
Screening for Amyloidosis Before Aortic Valve Elective Replacement
Previous studies detected that up to 15% of patients undergoing aortic valve replacement (AVR) for degenerative aortic stenosis have concomitant transthyretin amyloidosis (ATTR) cardiomyopathy (Castano, 2017).
- Trial name
- SAVER (NCT04869631)
- Testing
- The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center
Left Bundle Branch Block, Transcatheter Aortic Valve Replacement
HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients
TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that differ considerably between devices.
- Conditions
- Left Bundle Branch Block, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
- Trial name
- HESITATE (NCT02659137)
- Testing
- HV measurement
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Gradual Tapering or Discontinuation of Beta-Blockers After Stabilization With Mavacamten Therapy
This multicenter, randomized, open-label, parallel-group, non-inferiority trial will evaluate whether sequential tapering and discontinuation of beta-blockers is non-inferior to maintenance of the baseline stable beta-blocker…
- Trial name
- STEP-oHCM (NCT07815301)
- Testing
- Beta-Blocker Sequential Tapering and Discontinuation, Beta-Blocker Baseline Stable-Dose Maintenance
- Where
- China
- Volunteers
- 286 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Lung Injury
Acute Lung Injury After Aortic Valve Surgery
The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery.
- Trial name
- NCT01184313
- Testing
- aortic valve surgery with CPB
- Where
- Finland
- Volunteers
- 100 people
- Sponsor
- University of Oulu
Fabry Disease
Cardiac Involvement in Adult Patients With Fabry Disease; Relation to Enzyme Replacement Therapy
The purpose of this study was to assess the progression of cardiac involvement in adult patients with Fabry Disease (FD), in the unique Danish Fabry cohort and comparing those FD patients receiving primary therapy vs.
- Trial name
- NCT02908724
- Volunteers
- 66 people
- Sponsor
- Ulla Feldt-Rasmussen
Aortic Valve Stenosis, Aortic Valve Insufficiency
CryoValve® SG Aortic Human Heart Valve Combination Study
The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.
- Trial name
- SGAV (NCT01236469)
- Testing
- Echocardiogram
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- CryoLife, Inc.
Aortic Stenosis, Severe
Timing And Typology of ConducTIon disturbanCes During TAVI
The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational.
- Trial name
- TACTIC-TAVI (NCT06508866)
- Where
- Italy
- Volunteers
- 490 people
- Sponsor
- Istituto Clinico Humanitas
Aortic Stenosis Symptomatic, Aortic Valve Stenosis
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.
- Trial name
- RO-TAVI (NCT04694859)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Romania
- Volunteers
- 500 people
- Sponsor
- Romanian Society of Cardiology
Diastolic Dysfunction, Left Ventricular Hypertrophy
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of…
- Trial name
- NCT01188369
- Testing
- levosimendan
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- University of Aarhus
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
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