Clinical trials: Right Heart Insufficiency
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
Arrhythmogenic Right Ventricular Cardiomyopathy
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
- Trial name
- RIDGE-1 (NCT06228924)
- Testing
- TN-401
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- Tenaya Therapeutics
Acute Decompensated Heart Failure
Cardionomic STOP-ADHF Study
STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.
- Trial name
- NCT04814134
- Testing
- CPNS Therapy, Standard of care
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 59 people
- Sponsor
- Cardionomic Inc.
Pulmonary Hypertension, Congestive Heart Failure(CHF)
Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.
- Conditions
- Pulmonary Hypertension, Congestive Heart Failure(CHF), Valve Disease, Heart
- Trial name
- NCT07224906
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HemoCept Inc.
Heart Failure With Reduced Ejection Fraction (HFrEF)
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
This study is a small, early-stage clinical trial designed to test whether a new catheter-based procedure is safe and may help people with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- R-HFrEF (NCT07403058)
- Testing
- Right Greater Splanchnic Nerve (GSN) ablation
- Where
- 6 sites in Czechia, Poland and 2 more
- Volunteers
- 50 people
- Sponsor
- Axon Therapies, Inc.
Hypertension Pulmonary Secondary, Heart Failure, Right Sided
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
- Conditions
- Hypertension Pulmonary Secondary, Heart Failure, Right Sided, Heart Failure With Normal Ejection Fraction
- Trial name
- HELP (NCT03541603)
- Testing
- Levosimendan
- Where
- 16 sites in United States
- Volunteers
- 44 people
- Sponsor
- Tenax Therapeutics, Inc.
Fontan, Right Heart Failure
Cholate Clearance in Fontan and Heart Failure
The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease…
- Trial name
- NCT07009132
- Testing
- Dual cholate clearance assay, MRI
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
Heart Failure With Preserved Ejection Fraction (HFpEF
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve.
- Trial name
- Rebalance-HF (NCT04592445)
- Testing
- Greater Splanchnic Nerve Ablation
- Where
- 26 sites in United States, Georgia
- Volunteers
- 150 people
- Sponsor
- Axon Therapies, Inc.
Acute Decompensated Heart Failure
The STIM-ADHF Study
The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.
- Trial name
- NCT05313438
- Testing
- CPNS Therapy
- Where
- 6 sites in Hungary, Poland and 1 more
- Volunteers
- 13 people
- Sponsor
- Cardionomic Inc.
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 Failure
A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic…
- Trial name
- NCT07010562
- Testing
- Data collection
- Where
- Sweden
- Volunteers
- 392 people
- Sponsor
- Acorai AB
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 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
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Heart Failure
Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF)…
- Trial name
- NCT03071978
- Testing
- CRT with LV-only pacing / bi-ventricular pacing
- Where
- 5 sites in China
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Diseases, Hypertension, Pulmonary
Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery
Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery.
- Trial name
- NCT00458276
- Testing
- tezosentan
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 274 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Right Heart Failure
Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure
The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic…
- Trial name
- NCT07704424
- Testing
- CorVad Percutaneous Ventricular Assist System
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
- Conditions
- Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Trial name
- NCT03624010
- Testing
- Levosimendan
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- Tenax Therapeutics, Inc.
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices