Clinical trials: Biventricular Failure
Heart Failure, Biventricular Failure
BiVACOR® Total Artificial Heart Early Feasibility Study
The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left…
- Trial name
- NCT06174103
- Testing
- BiVACOR TAH System
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- BiVACOR Inc.
Atrial Fibrillation
MODULA Modul 7 VRR
This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial…
- Trial name
- NCT00180414
- Testing
- CRT devices with ventricular rate regulation [VRR] (CE labeled)
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
Single Dose Escalation Study in Patients With Chronic Heart Failure
This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design.
- Trial name
- NCT00565565
- Testing
- BAY60-4552
- Where
- 2 sites in Germany
- Volunteers
- 55 people
- Sponsor
- Bayer
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
Heart Failure
MultiPoint Pacing™ Post Market Study
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St.
- Trial name
- MPP-PMS (NCT02832622)
- Testing
- MPP, BiV/MPP
- Where
- 128 sites in United States, Argentina and 2 more
- Volunteers
- 2,169 people
- Sponsor
- Abbott Medical Devices
Biventricular Failure
SynCardia CardioWest TAH-t Postmarket Surveillance Study
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training…
- Trial name
- NCT00614510
- Testing
- CardioWest temporary Total Artificial Heart (TAH-t)
- Volunteers
- 196 people
- Sponsor
- SynCardia Systems. LLC
Heart Failure, Congestive, Ventricular Fibrillation
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
- Conditions
- Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- NCT00387803
- Testing
- Cardiac Resynchronization Therapy with Defibrillation
- Where
- United States
- Volunteers
- 581 people
- Sponsor
- Boston Scientific Corporation
Advanced Heart Failure
A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
- Trial name
- NCT07757451
- Testing
- DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
End-stage Heart Failure
Carmat TAH Early Feasibility Study
Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure.
- Trial name
- NCT04117295
- Testing
- Carmat Total Artificial Heart
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Carmat SAS
Advanced Heart Failure
DuoCor 2 DOMINATE Study
Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation.
- Trial name
- NCT07233876
- Testing
- DuoCor Ventricular Assist System
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Biventricular Failure
SynCardia Freedom Driver System Study
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System…
- Trial name
- NCT00733447
- Testing
- CardioWest temporary Total Artificial Heart (TAH-t) System
- Where
- 3 sites in United States
- Sponsor
- SynCardia Systems. LLC
Heart Failure
Triple-site Biventricular Stimulation in the Optimization of CRT
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the…
- Trial name
- TRIUMPH-CRT (NCT02350842)
- Testing
- triple-site biventricular pacing with peri-operative echo guidance, standard biventricular pacing
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Life-threatening, Biventricular Heart Failure
SynCardia 70cc TAH-t for Destination Therapy (DT)
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible…
- Conditions
- Life-threatening, Biventricular Heart Failure, Ineligible for Cardiac Transplant
- Trial name
- RA-540 (NCT02232659)
- Testing
- 70cc TAH-t for Destination Therapy
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- SynCardia Systems. LLC
Heart Failure
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex.
- Trial name
- V3 (NCT01059175)
- Testing
- Additional Endocardial or Epicardial LV Lead, CRT-P or CRT-D
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Heart Failure, Ventricular Dysfunction
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients…
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Trial name
- NCT00187213
- Testing
- Cardiac Resynchronization Therapy
- Where
- France
- Sponsor
- Abbott Medical Devices
Advanced Heart Failure
Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure
The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.
- Trial name
- EFICAS (NCT04475393)
- Testing
- Carmat Total Artificial Heart, Standard therapy for heart failure
- Where
- 10 sites in France
- Volunteers
- 104 people
- Sponsor
- Carmat SAS