Clinical trials: Valvulopathy, open to volunteers
Aortic Regurgitation Disease, Aortic Insufficiency
Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation
The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.
- Trial name
- NCT06835946
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- University of Liege
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
Mitral Valve Insufficiency
Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe.
- Trial name
- COHORTE-IM (NCT03962023)
- Testing
- Echocardiography and MRI
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Lille Catholic University
Valvular Heart Disease
Valvular Heart Disease Registry
Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of…
- Trial name
- NCT03488732
- Testing
- Transcatheter valvular repair or replacement
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Technical University of Munich
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Left Bundle-Branch Block, Aortic Valve Stenosis
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization…
- Trial name
- COME-TAVI (NCT03303612)
- Testing
- Pacemaker implant, Transcutaneous cardiac monitor
- Where
- 10 sites in Canada, France
- Volunteers
- 250 people
- Sponsor
- Montreal Heart Institute
Heart Failure, Kidney Diseases
Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes
- Conditions
- Heart Failure, Kidney Diseases, Kidney Injury, Heart Valve Diseases
- Trial name
- ODT-CRS (NCT05397392)
- Testing
- guideline recommended routine treatment
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Aortic Regurgitation
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical…
- Trial name
- NCT06101888
- Testing
- TaurusTrio™ Heart Valve System
- Where
- 19 sites in China
- Volunteers
- 116 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM)
AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA
The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in…
- Conditions
- Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Restrictive Cardiomyopathy
- Trial name
- Atlantis (NCT06748261)
- Testing
- CCTAI model
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05332691
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei
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
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Aortic Stenosis, Severe, Aortic Stenosis
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk.
- Trial name
- HOME-TAVI (NCT07738575)
- Testing
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Where
- 3 sites in Canada, Spain
- Volunteers
- 764 people
- Sponsor
- Hospital Clinic of Barcelona
Lumbar Spinal Stenosis, Cardiac Amyloidosis
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective.
- Conditions
- Lumbar Spinal Stenosis, Cardiac Amyloidosis, ATTR Amyloidosis Wild Type, ATTR Gene Mutation
- Trial name
- NCT06034405
- Testing
- Tc99-PYP or Tc99-HDMP Scan
- Where
- 6 sites in United States
- Volunteers
- 1,663 people, healthy volunteers welcome
- Sponsor
- Columbia University
Anemia, Iron Deficiencies
Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery
Postoperative anemia is highly prevalent among patients undergoing cardiac surgery and is associated with delayed functional recovery, increased morbidity, and impaired long-term outcomes.
- Conditions
- Anemia, Iron Deficiencies, Iron Deficiency Anemia, Cardiac Surgery
- Trial name
- NCT07238972
- Testing
- Ferric derisomaltose
- Where
- South Korea
- Volunteers
- 180 people
- Sponsor
- Yonsei University
Tricuspid Regurgitation (TR)
Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)
The study is focused on evaluation of the effectiveness of the Admittance Pulmonary Artery Catheter (PAC) system for assessing the right ventricular (RV) function in patients with tricuspid regurgitation (TR) prior to tricuspid…
- Trial name
- NCT07500025
- Testing
- Right Heart Catheterization
- Volunteers
- 8 people
- Sponsor
- Feldman Cardiology, PLLC
Mitral Regurgitation (MR)
Research on the Development and Application of a Preoperative Assessment Model for Transcatheter Mitral Valve Edge-to-Edge Repair Based on Visual Foundation Models
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks.
- Trial name
- NCT07247890
- Testing
- Model Construction, Validation, and Optimization
- Volunteers
- 800 people
- Sponsor
- Beijing Hospital