Clinical trials: Diseases of Aortic Valve
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Aortic Stenosis
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90)…
- Trial name
- PREDIC-TAVI (NCT07509554)
- Testing
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Left Bundle-Branch Block
Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker…
- Trial name
- MONITORTAVI (NCT06148883)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Aortic Stenosis
Non-contrast 3-dimensional Cardiac Magnetic Resonance Imaging
Non-contrast enhanced cardiac MRI using 3D whole heart acquisition protocol is non-inferior to contrast enhanced CT in the assessment of aortic annulus complex for pre-TAVR imaging.
- Trial name
- NCT04496297
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Baylor Research Institute
Bleeding, Von Willebrand Disease
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis
Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences.
- Conditions
- Bleeding, Von Willebrand Disease, Aortic Stenosis
- Trial name
- NCT00805051
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Stenosis
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular
Hypertrophic Cardiomyopathy
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
The purpose of this study is to determine whether taking losartan helps people with hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart muscle thickening and/or the amount of heart muscle…
- Trial name
- NCT01150461
- Testing
- losartan
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR)
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction.
- Conditions
- Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- Trial name
- TRANSLATE (NCT07455292)
- Testing
- Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Valve Stenosis
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking.
- Trial name
- REVALVE (NCT06557798)
- Testing
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
- Where
- 63 sites in Denmark, Finland and 9 more
- Volunteers
- 550 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Aortic Stenosis, Valvular Heart Disease
SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
The purpose of this study is to observe conduction disturbance, daily activity level, heart rates, oxygen saturation in patients who underwent Transcatheter Aortic Valve Replacement (TAVR) and to evaluate the utility of the…
- Conditions
- Aortic Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Replacement
- Trial name
- SMART TAVR (NCT04454177)
- Testing
- HUAWEI watch
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Stenosis
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.
- Trial name
- NCT02010177
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Cardiovascular Diseases, Heart Failure
Development of CIRC Technologies
Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization.
- Conditions
- Cardiovascular Diseases, Heart Failure, Ischemic Heart Disease, Non-ischemic Cardiomyopathy
- Trial name
- CIRC (NCT05654272)
- Testing
- MRI
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals.
- Trial name
- NCT04810195
- Testing
- Boston Scientific Acurate neo2 TAVR device
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 554 people
- Sponsor
- Andreas Rück
Aortic Regurgitation, Aortic Valve Insufficiency
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ART (NCT07453407)
- Testing
- J-VALVE Transfemoral Aortic Valve system, Commercially available surgical biological aortic valve replacement device
- Where
- 28 sites in China
- Volunteers
- 1,250 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Ascending Aorta Aneurism, Aortic Insufficiency
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
- Trial name
- EPSTAAA (NCT01456975)
- Testing
- Aortic valve reimplantation using Valsalva prosthesis
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Hypertrophic Cardiomyopathy
Genetic Predictors of Outcome in HCM Patients
This is a retrospective review of the data available on patients and their family members with HCM and prospective follow-up of this cohort for clinical outcome and diagnostic studies.
- Trial name
- NCT00156429
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Pittsburgh
Aortic Valve Stenosis
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI).
- Trial name
- PAPPI (NCT07442357)
- Testing
- Beta-lactam antibiotic with spectrum for Enterococcus faecalis, Cephalosporin
- Where
- 5 sites in Denmark, Sweden
- Volunteers
- 1,986 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Aortic Stenosis, Cardiac Valve Replacement Complication
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to…
- Conditions
- Aortic Stenosis, Cardiac Valve Replacement Complication, Fragility
- Trial name
- NCT01845207
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 800 people
- Sponsor
- Jewish General Hospital
Non-obstructive Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy
Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction ≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber…
- Trial name
- PACE-nHCM (NCT06775886)
- Testing
- myPACE+ algorithm
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Aortic Valve Disease
Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally…
- Trial name
- NIMO-TAVI (NCT05840757)
- Testing
- HemoSphere ClearSight Module
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- University of Basel
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