Clinical trials: Heart Valve Replacement
Sleep Disturbances, Postoperative Discomfort
Effect of Virtual Reality and Binaural Beat on Sleep and Comfort in Adults After Mechanical Valve Replacement Surgery
This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery.
- Conditions
- Sleep Disturbances, Postoperative Discomfort, Heart Valve Diseases
- Trial name
- VR-BBS (NCT07365488)
- Testing
- Virtual Reality Relaxation, Binaural Beat Stimulation, VR + Binaural Beat Group
- Where
- Iraq
- Volunteers
- 140 people
- Sponsor
- University of Baghdad
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Diastolic Dysfunction
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.
- Trial name
- DANAVR (NCT03972644)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 1,700 people
- Sponsor
- Odense University Hospital
Aortic Valve Stenosis
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
- Trial name
- REBOOT-PARADOX (NCT03863132)
- Testing
- TAVR
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Aortic Valve Stenosis
The Asian Pacific TAVR Multicenter Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
- Trial name
- AP TAVR (NCT02195102)
- Testing
- Transcatheter aortic valve Replacement
- Where
- 10 sites in China, Japan and 6 more
- Volunteers
- 2,000 people
- Sponsor
- Michael Kang-Yin Lee, MD
Aortic Valve Disease, Surgery--Complications
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are…
- Conditions
- Aortic Valve Disease, Surgery--Complications, Immune System Disorder
- Trial name
- Measure (NCT04430972)
- Testing
- Aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Aortic Valve Disease
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
- Trial name
- NCT02458560
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 27 sites in Australia, Denmark and 7 more
- Volunteers
- 203 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Limited Access Aortic Valve Replacement
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS).
- Conditions
- Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life
- Trial name
- LIAR (NCT04012060)
- Testing
- Limited access aortic valve replacement., Conventional aortic valve replacement
- Where
- Netherlands
- Volunteers
- 161 people
- Sponsor
- St. Antonius Hospital
Aortic Stenosis
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve…
- Trial name
- NCT03095313
- Testing
- 18F-NaF
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
ATTR Amyloidosis Wild Type, Severe Aortic Stenosis
Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known.
- Conditions
- ATTR Amyloidosis Wild Type, Severe Aortic Stenosis, Aortic Valve Stenosis, Middle East Studies
- Trial name
- NCT06015997
- Volunteers
- 100 people
- Sponsor
- Jordan Collaborating Cardiology Group
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Stenosis
Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- HBCR-TAVR (NCT04166682)
- Testing
- Home-based cardiac rehabilitation, Routine care
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Right Ventricular Dysfunction
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve…
- Trial name
- NCT05804240
- Testing
- 3D TEE RVEF
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Thomas Jefferson University
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years).
- Conditions
- Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening, Valve Expansion, Transcatheter Aortic Valve Replacement
- Trial name
- SYMMETRY (NCT07872020)
- Testing
- Double-TAP post-dilatation
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 422 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis
Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
Background: Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR.
- Trial name
- NCT02280824
- Testing
- CA-TAVR, Amplatzer Duct Occluder
- Where
- 15 sites in United States
- Volunteers
- 172 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Stenosis, Cerebral Ischaemic Injury
Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）
Transcatheter aortic valve replacement (TAVR) has become the most anticipated treatment method in the cardiovascular field in recent years, experiencing rapid development.
- Trial name
- PISTNT (NCT07087379)
- Testing
- Intensive statin treatment
- Volunteers
- 500 people
- Sponsor
- Pan Xiangbin
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty
In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve…
- Trial name
- NCT05189886
- Testing
- Double Balloon Valvuloplasty in TAVR
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Community Memorial Health System