Clinical trials: Right Ventricular Congenital Cardiopathies
Brugada Syndrome
Right Ventricle Morphology and Hemodynamics in BrS
The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR…
- Trial name
- RV-BrS (NCT03524079)
- Testing
- Ajmaline 17-(Chloroacetate) Monohydrochloride
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- IRCCS Policlinico S. Donato
Congenital Heart Disease
Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction
The study is a prospective, non-randomised, open label clinical study to assess the safety of the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22 years of age, undergoing Right Ventricular…
- Trial name
- NCT02700100
- Testing
- Bioabsorbable Pulmonary Valved Conduit (PV-001)
- Where
- 3 sites in Hungary, Malaysia and 1 more
- Volunteers
- 12 people
- Sponsor
- Xeltis
Heart Septal Defects, Ventricle, Heart Defects, Congenital
Genes Causing Ebstein's Anomaly
This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid valve of the heart and try to identify the genetic origins of the disease.
- Conditions
- Heart Septal Defects, Ventricle, Heart Defects, Congenital, Double Outlet Right Ventricle, Truncus Arteriosus, Persistent
- Trial name
- NCT00497705
- Where
- 3 sites in United States, Belarus and 1 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Systemic Right Ventricle, Tricuspid Regurgitation
Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort (PETER-TRESRIV)
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve…
- Conditions
- Systemic Right Ventricle, Tricuspid Regurgitation, Congenital Heart Disease
- Trial name
- PETER-TRESRIV (NCT05052177)
- Testing
- Edge to edge repair in systemic tricuspid valve regurgitation
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University of Bordeaux
Valvulopathy
Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction
Prospective Study, Single Arm to evaluate the safety and efficacy of polyurethane expandable valve implantation in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to…
- Trial name
- NCT05289622
- Testing
- Polyurethane expandable valve stent implant
- Where
- Brazil
- Volunteers
- 5 people
- Sponsor
- Dr. Miguel Angel Maluf
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Inherited Cardiac Arrhythmias, Long QT Syndrome
Long Term Monitoring for Risk of Sudden Death
Risk prediction in in inherited heart rhythm conditions that may cause sudden cardiac arrest or death is difficult. Sometimes the risks may be low but the loss of life in an otherwise healthy young individual is catastrophic.
- Conditions
- Inherited Cardiac Arrhythmias, Long QT Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy, Brugada Syndrome
- Trial name
- NCT04124237
- Where
- Canada
- Volunteers
- 1,051 people
- Sponsor
- University of British Columbia
Congenital Heart Disease
Study of RV Remodeling in Congenital Heart Disease
The primary aims of this study are to 1. Develop an automated method of quantitation of RV remodeling in terms of regional RV surface curvature and area strain and assess the feasibility, repeatability and accuracy in normal…
- Trial name
- RVShape (NCT02791061)
- Testing
- Cardiovascular Magnetic Resonance Imagine (MRI), Cardiopulmonary exercise testing (CPET), Echocardiography
- Where
- Singapore
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- National Heart Centre Singapore
Cardiomyopathies, Heart Diseases
PKP2-ACM Natural History Study
The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.
- Conditions
- Cardiomyopathies, Heart Diseases, Cardiovascular Diseases, Genetic Diseases
- Trial name
- NCT06644742
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 36 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Transposition of the Great Arteries, Systemic Right Ventricle
Systemic Right Ventricle Long-term Outcome
Patients with the transposition of great arteries (TGA) who undergo atrial switch operation and congenitally corrected TGA (ccTGA) patients have the right ventricle as their systemic ventricle.
- Trial name
- SINCERE (NCT06258083)
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 542 people
- Sponsor
- University Medical Center Groningen
Sarcoidosis, Arrhythmogenic Right Ventricular Cardiomyopathy
PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue.
- Trial name
- NCT02989480
- Testing
- PET CT, Cardiac MRI
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- University of Aberdeen
Cyanotic Congenital Heart Disease, Right Ventricular Outflow Tract Obstruction
RVOT Stenting Versus Surgical RV-PA Conduit in Cyanotic Adults
This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in…
- Trial name
- NCT07866911
- Volunteers
- 30 people
- Sponsor
- Assiut University
Fabry Disease, Cardiac Variant, Right Ventricular Hypertrophy
Myocardial Affectation in Patients With Fabry Disease Without Phenotypic Manifestation. Diagnostic Value of Biomarkers
The cardiac variant of the Fabry disease is a rare cardiomyopathy affecting 1/50000 individuals in general population. It is generally diagnosed in advanced stages of the disease, because it presents clinical features very…
- Trial name
- FAMY (NCT01442350)
- Volunteers
- 120 people
- Sponsor
- Francisco Marín Ortuño
Tetralogy of Fallot With Pulmonary Stenosis
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at 35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or pulmonary regurgitation (PR).
- Trial name
- NCT02186691
- Testing
- MRI
- Where
- France
- Volunteers
- 11 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT)
Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies
TRACE-ACM is a multicenter, retrospective, observational study of patients with arrhythmogenic cardiomyopathy who received an implantable cardioverter-defibrillator (ICD) and had documented ventricular tachyarrhythmias.
- Conditions
- Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation, ICD
- Trial name
- TRACE-ACM (NCT07688200)
- Volunteers
- 300 people
- Sponsor
- Policlinico Casilino ASL RMB
Arrhythmias, Cardiac, Atrial Fibrillation
Clinical Cohort Study - TRUST
The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical…
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- TRUST (NCT05521451)
- Where
- Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Arrhythmogenic Cardiomyopathy, PKP2-ACM
Long-term Follow-up Study of Gene Therapy for Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant
The primary objective of this Phase 1/2 long-term follow-up (LTFU) study is to assess the long-term safety and tolerability of LX2020 for the treatment of arrhythmogenic cardiomyopathy (ACM) due to a plakophilin-2 gene (PKP2)…
- Conditions
- Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC
- Trial name
- GRIT-PKP2 (NCT07050160)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lexeo Therapeutics
Brugada Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy
Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome
The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients and its higher sensitivity when compared to…
- Trial name
- NCT02302274
- Testing
- flecainide iv
- Where
- United States
- Volunteers
- 209 people
- Sponsor
- NYU Langone Health
Heart-lung Interaction, Right Ventricular Hypertrophy
Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy
Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort.
- Conditions
- Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care, Congenital Heart Disease
- Trial name
- NCT04825054
- Testing
- Mechanical ventilation with NAVA mode, Mechanical ventilation with PCV mode, Mechanical ventilation with PSV mode
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Limin Zhu
Dilated Cardiomyopathy, Heart Failure
Assessment of Right Ventricular Function in Advanced Heart Failure
We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy…
- Trial name
- NCT03893760
- Testing
- Ventriculo-arterial coupling assessment (R-V/A)
- Where
- 2 sites in Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ITAB - Institute for Advanced Biomedical Technologies