Clinical trials: Pulmonary Regurgitation, active
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
Pulmonary Valve Insufficiency
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
- Trial name
- GECT (NCT05809856)
- Testing
- GrOwnValve - novel heart valve replacement approach
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Charite University, Berlin, Germany
Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive
The FOCUS-ADHF Registry
Acute heart failure (AHF) represents a significant clinical and economic burden due to its impact on patients' quality of life, poor prognosis, and high healthcare costs.
- Conditions
- Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive, Regurgitation, Mitral
- Trial name
- FOCUS-ADHF (NCT06726109)
- Where
- 4 sites in Belgium, Italy
- Volunteers
- 600 people
- Sponsor
- ASL Città di Torino
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation
The CardioClip Study
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin.
- Trial name
- CardioClip (NCT06241430)
- Testing
- CardioMEMS
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 people
- Sponsor
- Medtronic Cardiovascular
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Tetralogy of Fallot, Pulmonary Regurgitation
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year.
- Trial name
- NCT04084132
- Testing
- Pulmonary valve replacement
- Where
- 3 sites in Denmark
- Volunteers
- 120 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Pulmonary Regurgitation
VenusP-Valve Pivotal Study (PROTEUS STUDY)
A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.
- Trial name
- PROTEUS (NCT06010563)
- Testing
- Transcatheter pulmonary valve implantation (TPVI), VenusP-ValveTM System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Diabete Type 2, Regurgitation
Investigation of Gastric Emptying by Gastric Ultrasonography in Diabetic Patients Treated With GLP-1 Receptors
Treatment with semaglutide slows down gastric emptying , food remains in the stomach for a longer period of time. This slowing has important implications for anesthesia management.
- Conditions
- Diabete Type 2, Regurgitation, Pulmonary Aspiration During Anaesthetic Induction
- Trial name
- SAGUSE (NCT07506356)
- Where
- Switzerland
- Volunteers
- 38 people
- Sponsor
- University Hospital, Geneva
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Tricuspid Regurgitation, Pulmonary Regurgitation
Berlin Registry of Right Heart Interventions
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo.
- Trial name
- NCT04570163
- Testing
- Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Prospective Evaluation of AI-ECG for SHD Detection
AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing…
- Conditions
- Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- Trial name
- AI-ECG-SHD (NCT07057466)
- Testing
- Traditional 12-lead Electrocardiogram, Apple Watch Series 4 Single-lead Electrocardiogram, Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram
- Where
- 6 sites in United Kingdom
- Volunteers
- 590 people
- Sponsor
- Imperial College London
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease.
- Conditions
- Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF), Pulmonary Regurgitation, Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor
- Trial name
- STEPS (NCT06668389)
- Testing
- SGLT2 inhibitor (Dapagliflozin 10mg)
- Where
- Hong Kong
- Volunteers
- 106 people
- Sponsor
- The University of Hong Kong
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences