Clinical trials: Left-Sided Heart Failure
Heart Failure
Evaluation of Left Ventricular Autothreshold, Phase Two
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
- Trial name
- ELEVATE 2 (NCT01242722)
- Testing
- CRT-D
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
REDUCE LAP-HF III Corvia Protocol 1701
This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System…
- Trial name
- REDUCELAPHFIII (NCT03191656)
- Testing
- IASD Implant
- Where
- 27 sites in Germany, Switzerland
- Volunteers
- 500 people
- Sponsor
- Corvia Medical
Severe Functional Mitral Regurgitation and Heart Failure
Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
- Trial name
- LVRECOVER (NCT02153892)
- Testing
- GDS Accucinch System
- Where
- Australia
- Volunteers
- 2 people
- Sponsor
- Ancora Heart, Inc.
Heart Failure, Cardiac Failure
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Heart Failure, Left-sided
- Trial name
- NCT02205411
- Testing
- HeartAssist 5® VAD System, Control VAD
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- ReliantHeart Inc.
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US.
- Trial name
- QP ExCELs (NCT02290028)
- Testing
- Sentus QP left ventricular lead
- Where
- 119 sites in United States, Australia and 9 more
- Volunteers
- 2,226 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Model 4396 Left Ventricular (LV) Lead Study
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective.
- Trial name
- 4396 (NCT00853593)
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 197 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure