Clinical trials: Heart Failure NYHA Class IV
Heart Failure, Heart Failure NYHA Class III
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms.
- Conditions
- Heart Failure, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction, Ambulatory Heart Failure, NYHA Class IV
- Trial name
- EASE HF2 (NCT06859970)
- Testing
- PAS-C System
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- InterShunt Technologies, Inc.
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
- Trial name
- NCT02645539
- Testing
- intravascular ventricular assist system (iVAS)
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- NuPulseCV
Congestive Heart Failure
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device.
- Trial name
- CLEPSYDRA (NCT00957541)
- Testing
- Paradym CRT + Physiological Diagnosis (PhD)
- Where
- United States
- Volunteers
- 520 people
- Sponsor
- ELA Medical, Inc.
Heart Failure
Optimal Balance Alfapump® System Feasibility Study
1. Summary of Clinical Investigation A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the…
- Trial name
- OPTIMALBALANCE (NCT03032211)
- Testing
- Alfapump
- Where
- Hungary
- Sponsor
- Sequana Medical N.V.
Heart Failure, Cardiomyopathy
Clinical Evaluation on Advanced Resynchronization
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
- Trial name
- NCT00658203
- Testing
- New Living CHF
- Where
- 36 sites in France, Germany and 4 more
- Volunteers
- 310 people
- Sponsor
- LivaNova
Heart Failure With Preserved Ejection Fraction
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
- Trial name
- PARAGON-HF (NCT01920711)
- Testing
- LCZ696, Valsartan
- Where
- 715 sites in United States, Argentina and 41 more
- Volunteers
- 4,822 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Left Bundle-Branch Block
Mid-Q Response Study
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II
- Trial name
- NCT04180696
- Testing
- aCRT ON, aCRT OFF
- Where
- 61 sites in Brunei, China and 8 more
- Volunteers
- 177 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.
- Trial name
- NCT05236673
- Testing
- JARDIANCE®
- Where
- 21 sites in South Korea
- Volunteers
- 676 people
- Sponsor
- Boehringer Ingelheim
Chronic Heart Failure
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure…
- Trial name
- ATMOSPHERE (NCT00853658)
- Testing
- Enalapril, Aliskiren
- Where
- 806 sites in United States, Argentina and 42 more
- Volunteers
- 7,064 people
- Sponsor
- Novartis Pharmaceuticals
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
Heart Failure
Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants
This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.
- Trial name
- Biso-CHF (NCT03026088)
- Testing
- Bisoprolol
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Heart Failure
Safety and Performance Evaluation of CircuLite Synergy
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
- Trial name
- NCT00878527
- Testing
- CircuLite Synergy Pocket Circulatory Assist Device
- Where
- 11 sites in Belgium, Germany and 3 more
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
NYHA Class III Heart Failure, NYHA Class IV Heart Failure
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.
- Trial name
- FIX-HF-5C (NCT01381172)
- Testing
- Optimizer System, No intervention: Optimal medical therapy
- Where
- 42 sites in United States, Czechia and 1 more
- Volunteers
- 160 people
- Sponsor
- Impulse Dynamics
Diastolic Heart Failure NYHA Class III-IV, Diastolic Dysfunction Secondary to Aortic Stenosis
CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction
The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".
- Trial name
- NCT01956526
- Testing
- CORolla™ TAA device
- Where
- 2 sites in Italy
- Volunteers
- 12 people
- Sponsor
- CorAssist Cadiovascular Ltd.
Heart Failure NYHA Class III and Ambulatory IV
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization…
- Trial name
- RESPOND-CRT (NCT01534234)
- Testing
- PARADYM RF SONR
- Where
- 125 sites in United States, Australia and 10 more
- Volunteers
- 1,039 people
- Sponsor
- MicroPort CRM
Heart Failure, Congestive
Study of DITPA in Patients With Congestive Heart Failure
This study will assess the safety and efficacy of DITPA relative to placebo in patients with New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low serum T3.
- Trial name
- NCT00103519
- Testing
- DITPA (3,5-diiodothyropropionic acid)
- Where
- 22 sites in United States
- Volunteers
- 86 people
- Sponsor
- Titan Pharmaceuticals
Heart Failure, Heart Failure NYHA Class II
Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF
The BEDICARE-HF study aims to go further in the research on digital support. The objectives of this study are to demonstrate the feasibility, acceptability, adoption, sustainability and safety of a of a smartphone-based digital…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- BEDICARE-HF (NCT05487365)
- Testing
- Comunicare Solutions Smartphone Application, Completing a quality of life (QOL)-questionnaire
- Where
- Belgium
- Volunteers
- 330 people
- Sponsor
- Comunicare Solutions SA
Hypertension (HTN), NYHA Class III Heart Failure
Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001 Low) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to…
- Conditions
- Hypertension (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure, Diabete Mellitus
- Trial name
- NCT07064525
- Testing
- SPC1001 Low, SPC5002, SPC5003
- Where
- South Korea
- Volunteers
- 252 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Heart Failure (NYHA Class III and Ambulatory IV)
Continued Access Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm…
- Trial name
- RESPOND-CAS (NCT02374801)
- Testing
- SonR automatic optimization feature turned ON ("AV+VV").
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- MicroPort CRM
Heart Failure, Congestive
ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure
The main purpose of this study is to see if the experimental drug ZP120, when given with the approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the amount of fluid in the patients' lungs and…
- Trial name
- NCT00283361
- Testing
- ZP120, I.v. catherization, 6-minutes walk performance
- Where
- 22 sites in United States
- Volunteers
- 130 people
- Sponsor
- Zealand Pharma