Clinical trials: Right Side
Native Right Ventricle Outflow Tract(RVOT) Dysfunction
VenusP-Valve™ System Long-term Follow-up 6-10 Years
The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system…
- Trial name
- NCT07531303
- Volunteers
- 55 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
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
Right Ventricular Outflow Tract Dysfunction
Observational Study of Venus P-Valve
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with…
- Trial name
- Registry (NCT05835349)
- Testing
- transcatheter pulmonary valve implantation (TPVI)
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 200 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
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.
Microbiota
Project SHARE (motherS Have All the Right microbEs)
This is an exploratory study designed to collect microbial samples from several body locations from 6 pairs of mothers and their newborn infants at various time points.
- Trial name
- NCT03239197
- Where
- United States
- Sponsor
- Kimberly-Clark Corporation
Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
Melody® Transcatheter Pulmonary Valve Post-Approval Study
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
- Trial name
- NCT01186692
- Testing
- Melody® Transcatheter Pulmonary Valve
- Where
- 10 sites in United States
- Volunteers
- 131 people
- Sponsor
- Medtronic Cardiovascular
Pulmonary Arterial Hypertension
Assessmet of Patients With PAH Right Ventricular Volume
The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with…
- Trial name
- NCT01557582
- Testing
- Ventripoint Medical System
- Where
- 7 sites in United States, Canada
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- VentriPoint Diagnostics Ltd.
Heart Defect, Congenital
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract…
- Trial name
- Xplore2 (NCT03022708)
- Testing
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Where
- 10 sites in United States, Bulgaria and 2 more
- Volunteers
- 6 people
- Sponsor
- Xeltis
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S.
- Trial name
- DISRUPT (NCT04160468)
- Testing
- Exebacase
- Where
- 55 sites in United States
- Volunteers
- 259 people
- Sponsor
- ContraFect
Right Ventricular Failure
CentriMag RVAS U.S. Post-approval Study Protocol
The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any…
- Trial name
- CMagRVAS (NCT01568424)
- Testing
- CentriMag RVAS placement
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation
Heart Failure, Univentricular Heart
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks…
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases
- Trial name
- RegiVe (NCT04782232)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Berlin Heart GmbH
Heart Defects, Congenital
Xeltis Pulmonary Valved Conduit Safety and Performance Study
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or…
- Trial name
- NCT03405636
- Testing
- Xeltis Pulmonary Valved Conduit
- Where
- 4 sites in Hungary, Malaysia and 2 more
- Sponsor
- Xeltis
Pulmonary Hypertension
Measurements and Characterization of Doppler Signals From the Right Chest in Pediatric and Adult Patients
Recently it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package parametric Doppler, TPD…
- Trial name
- NCT01913457
- Testing
- Ultrasound Doppler
- Where
- 2 sites in United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Echosense Ltd.
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs
Right Ventricular (RV) Dysfunction
Impella RP Flex with Smart Assist
To capture observational data of the Abiomed Impella RP Flex in a real-world setting.
- Trial name
- NCT06637644
- Testing
- Right-sided ventricular assist device
- Where
- 31 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abiomed Inc.
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review.
- Trial name
- NCT00740870
- Testing
- Transcatheter Pulmonary Valve replacement
- Where
- 5 sites in United States
- Volunteers
- 171 people
- Sponsor
- Medtronic Cardiovascular
Heart Failure, Right-Sided, Cardiac Failure
Syncardia 50cc TAH-t as a Bridge to Transplant
The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support…
- Conditions
- Heart Failure, Right-Sided, Cardiac Failure, Heart Failure, Left-Sided
- Trial name
- NCT02459054
- Testing
- SynCardia 50cc temporary Total Artificial Heart (TAH-t)
- Where
- 26 sites in United States
- Volunteers
- 16 people
- Sponsor
- SynCardia Systems. LLC
Ankle Injuries, Syndesmotic Injuries
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT04893824
- Testing
- Grappler® Interference Screw System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paragon 28
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