Clinical trials: Valve-in-valve Procedures
Acute Coronary Syndromes
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a…
- Trial name
- NCT02415400
- Testing
- Apixaban, vitamin K antagonist, Acetylsalicylic acid
- Where
- 626 sites in United States, Argentina and 35 more
- Volunteers
- 4,614 people
- Sponsor
- Bristol-Myers Squibb
PROM, Patient Reported Outcomes
Patient Reported Outcomes (PROMs) in Transcatheter Aortic Valve Implantation (TAVI) Patients
The transcatheter Aortic Valve Implantation (TAVI) population with severe aortic stenosis (AS) is characterized by advanced age (most patients are octogenarians) and multiple comorbidities.
- Conditions
- PROM, Patient Reported Outcomes, Transcatheter Aortic Valve Implantation
- Trial name
- NCT05808907
- Testing
- Questionnaire
- Where
- Israel
- Volunteers
- 250 people
- Sponsor
- Rabin Medical Center
Atrial Fibrillation
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
- Trial name
- NCT01107730
- Testing
- Vitamin C, L-Carnitine
- Where
- Greece
- Volunteers
- 33 people
- Sponsor
- Attikon Hospital
Extracorporeal Circulation; Complications, Air Embolism
Comparing Air Embolic Load in Two Venous Cannulation Methods, 40 Patients Undergoing Elective Valve Surgery.
The goal of this single center prospective controlled observational and interventional trial is to investigate and compare origin of air emboli when different venous cannulation methods is used in patients undergoing cardiac…
- Trial name
- NCT05820828
- Testing
- Volume control
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Petronella Torild
Mitral Valve Disease
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
- Trial name
- NCT04954404
- Testing
- transcatheter mitral valve repair/transcatheter mitral valve replacement
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Endocarditis, Bacterial, Endocarditis
Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis
Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions.
- Conditions
- Endocarditis, Bacterial, Endocarditis, Endocarditis Acute and Subacute
- Trial name
- PROPHETS (NCT05613933)
- Testing
- Improved practices
- Volunteers
- 250,000 people
- Sponsor
- University Hospital, Bordeaux
Elderly Heart Valve Surgery, Silent Aspiration
Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients
Objective To investigate the safety and effectiveness of interference electrical stimulation in the prevention of silent aspiration after heart valve surgery in elderly patients.
- Trial name
- SILENT-HV (NCT07710001)
- Testing
- The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071), Usual Care Group
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Fujian Medical University Union Hospital
Aortic Stenosis, Sedation Complication
High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers
Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications.
- Trial name
- HIGH-OXY-TAVR (NCT05958537)
- Testing
- High flow nasal oxygen
- Where
- Spain
- Volunteers
- 132 people
- Sponsor
- Hospital Clinic of Barcelona
Amyloidosis Cardiac, Stenosis Coronary
Non-Interventional Study on the Prevalence of Cardiac Amyloidosis in Patients With Higher-Grade Aortic Valve Stenosis - Evaluation Using Echocardiography, Computed Tomography, Tc99-SPECT/CT and Cardiac Magnetic Resonance Imaging (CMR)
Degenerative aortic stenosis (AS) is frequently accompanied by left ventricular hypertrophy and diastolic dysfunction, features that overlap with transthyretin (ATTR) cardiac amyloidosis.
- Conditions
- Amyloidosis Cardiac, Stenosis Coronary, TAVI(Transcatheter Aortic Valve Implantation)
- Trial name
- NIS-TAVI-AMY (NCT07752732)
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- University Hospital Tuebingen
Mitral Valve Stenosis and Insufficiency, Atrial Fibrillation
Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses
The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.
- Trial name
- NCT03183843
- Testing
- Dabigatran Etexilate, Warfarin
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Atrial Fibrillation, Coronary Artery Disease
Dabigatran Versus Warfarin With NVAF Who Undergo PCI
This study is to compare the efficacy and safety of dabigatran ethidium b.i.d.+ clopidogrel + ASA [100 mg q.d. *1 month] and warfarin + clopidogrel + ASA [100 mg, q.d.*1 month] in Chinese NVAF patients undergoing PCI with…
- Trial name
- COACH-AF-PCI (NCT03536611)
- Testing
- dabigatran, warfarin
- Where
- China
- Volunteers
- 1,120 people
- Sponsor
- Shenyang Northern Hospital
Aortic Valve Disease
Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases
Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients.
- Trial name
- NCT04816851
- Testing
- OZAKI technique
- Where
- Egypt
- Volunteers
- 1 people
- Sponsor
- Assiut University
Prehabilitation, Cardiac Surgery
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery.
- Conditions
- Prehabilitation, Cardiac Surgery, Risk Assesment, Aortic Valve
- Trial name
- PREPA-STER (NCT07893184)
- Testing
- Physical Prehabilitation Intervention
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Maastricht University Medical Center
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
Mitral Regurgitation, Mitral Valve Insufficiency
Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate…
- Trial name
- PMVI-PiP (NCT04156295)
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Severe Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
- Trial name
- PATHFINDER (NCT07321899)
- Testing
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Where
- 13 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center
Hypertrophic Cardiomyopathy, Arrhythmia
Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias
The goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal Radiofrequency Ablation.
- Trial name
- NCT06031519
- Testing
- Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)
- Where
- China
- Volunteers
- 350 people
- Sponsor
- Xijing Hospital
AORTIC VALVE DISEASES, Valve-in-valve Procedures
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic…
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Trial name
- REVIVAL (NCT07524595)
- Testing
- Hydra THV Series, Sapien THV Series and MyVal THV Series
- Where
- Ireland
- Volunteers
- 111 people
- Sponsor
- National University of Ireland, Galway, Ireland
Respiratory Failure, Communication Disorders
Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase.
- Conditions
- Respiratory Failure, Communication Disorders, Depression, Quality of Life
- Trial name
- NCT07005596
- Testing
- Passy-Muir Speaking Valve, Standard Non-Verbal Communication Methods
- Volunteers
- 70 people
- Sponsor
- Far Eastern Memorial Hospital