Clinical trials: Cardiac Resynchronisation Therapy (CRT)
Pacemaker Therapy, Cardiac Resynchronization Therapy
BIO|MASTER.Edora Family Study
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions.
- Trial name
- NCT03091322
- Testing
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
- Where
- 11 sites in Austria, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia, Cardiac Resynchronization Therapy
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- POLARIS (NCT06453850)
- Testing
- Use of FLEXIGO delivery catheter
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 216 people
- Sponsor
- MicroPort CRM
Heart Failure
OptiVol® Care Pathway
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States.
- Trial name
- NCT00847288
- Testing
- Monthly Review Arm, Quarterly Review Arm
- Where
- 108 sites in United States
- Volunteers
- 1,682 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Attain Performa(TM) Quadripolar Lead Study
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure.
- Trial name
- NCT01751022
- Testing
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Where
- 121 sites in United States, Australia and 25 more
- Volunteers
- 1,202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure (CHF)
Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump…
- Trial name
- NCT00528320
- Testing
- Ovatio CRT
- Sponsor
- ELA Medical, Inc.
Heart Failure
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
- Trial name
- PEGASUS CRT (NCT00146848)
- Testing
- Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
- Where
- United States
- Volunteers
- 1,742 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
Cardiac Resynchronization Therapy (CRT) Efficacy Study
The aim of this research study is the invasive evaluation of CR therapy efficacy in patients treated with an InSync Sentry device using an external monitoring device to obtain important cardiac parameters.
- Trial name
- NCT00822146
- Testing
- CRT
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
- Trial name
- NCT01519739
- Testing
- MediGuide™
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device…
- Trial name
- NCT02698241
- Testing
- Diagnostic & Medication Management
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Left Bundle Branch Block
High Septal Pacing for Cardiac Resynchronization Therapy
The purpose of this acute study is to perform a preliminary investigation of high septal right ventricular pacing in the vicinity of the His bundle region as an alternate or adjunctive means for cardiac resynchronization in…
- Conditions
- Heart Failure, Left Bundle Branch Block, Heart Disease
- Trial name
- HISTORY (NCT01325480)
- Testing
- Cardiac Pacing
- Where
- Hong Kong
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Unspecified
Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St.
- Trial name
- NCT03001141
- Testing
- Observational
- Where
- 4 sites in Brazil
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Chronic Heart Failure
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
Researchers are looking for a better way to treat people who have chronic heart failure. Chronic heart failure is a medical condition with shortness of breath, tiredness and ankle swelling in which the heart does not pump blood…
- Trial name
- REMOTE-HF (NCT05532046)
- Testing
- BAY2413555 Dose 1, BAY2413555 Dose 2
- Where
- 18 sites in United States, Denmark and 4 more
- Volunteers
- 22 people
- Sponsor
- Bayer
Heart Failure
QuickOpt Chronic Study
The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the…
- Trial name
- NCT01172067
- Testing
- Cardiac Resynchronization Therapy, Optimization using echocardiography
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
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
Congestive Heart Failure Treated
Clinical Benefits in Optimized Remote HF Patient Management
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or…
- Trial name
- COR-HF (NCT01482598)
- Testing
- Remote Care Follow up
- Where
- 18 sites in Italy
- Volunteers
- 144 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy With Obstruction
Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
This investigation is a prospective, randomized, single-blinded and multicenter design. The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic…
- Trial name
- TRICHAMPION (NCT01614717)
- Testing
- CRT-P Implant
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices