Clinical trials: Cardiac Resynchronization Therapy
Heart Failure
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute, prospective, non-randomized multi-center feasibility clinical trial.
- Trial name
- NCT01609985
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Detection of Phrenic Nerve Stimulation Using Sensors' Signals
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
- Trial name
- DETECT PS (NCT01233323)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
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.
Magnetic Resonance Imaging
ENABLE MRI (Magnetic Resonance Imaging)
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled…
- Trial name
- ENABLE-MRI (NCT02652481)
- Testing
- ImageReady MR Conditional Defibrillation System
- Where
- 57 sites in United States, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Indication for Cardiac Resynchronization Therapy (CRT)
Evia/Entovis HF-T Master Study
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers.
- Trial name
- NCT01545739
- Testing
- Evia/Entovis HF-T pacemaker for CRT therapy
- Where
- Hungary
- Volunteers
- 122 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
- Trial name
- SOLVE-CRT (NCT02922036)
- Testing
- WiSE System
- Where
- 68 sites in United States, Australia and 5 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- EBR Systems, Inc.
Heart Failure, Cardiomyopathy
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
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
- NCT00289302
- Testing
- Cardiac resynchronization therapy device
- Where
- 51 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.
- Trial name
- ALSYNC (NCT01277783)
- Testing
- Endocardial Left Ventricular pacing
- Where
- 18 sites in Belgium, Canada and 5 more
- Volunteers
- 138 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
Cardiac Resynchronization Therapy, Chronic Heart Failure
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from…
- Conditions
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- Trial name
- CRT-DRIVE (NCT05327062)
- Testing
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Where
- 13 sites in United States, Austria and 5 more
- Volunteers
- 150 people
- Sponsor
- XSpline S.p.A.
Heart Failure
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)
- Trial name
- MADIT-CRT PAR (NCT01294449)
- Testing
- MADIT-CRT ICD, MADIT-CRT CRT-D
- Where
- United States
- Volunteers
- 394 people
- Sponsor
- Boston Scientific Corporation
Cardiac Resynchronization Therapy, Heart Failure
Septal Mapping And Resynchronisation Therapy- (SMART) Study
Normal heart function involves rhythmic contraction of all four chambers of the heart and this rhythm is maintained by the electrical wiring (conduction system) of the heart.
- Trial name
- NCT04595305
- Testing
- Cardiac resynchronization therapy by CRT-P or CRT-D implantation
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
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
Care-HF CArdiac Resynchronization in Heart Failure
The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal…
- Trial name
- NCT00170300
- Testing
- Implantable Cardiac Resynchronisation (pacing) device
- Volunteers
- 813 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Arrhythmias, Cardiac
Japanese Assessment of Indication Based Programming
The purpose of this clinical investigation is to assess the programming behavior of the physicians in the patient cohort. Furthermore, the acceptance level of specific programming recommendations based on the patient's clinical…
- Trial name
- JASMINE (NCT01143220)
- Testing
- No specific interventions
- Where
- 45 sites in Japan
- Volunteers
- 235 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Cardiac Resynchronization Therapy
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium.
- Trial name
- BIO|REDUCE (NCT03839121)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 21 sites in Austria, Czechia and 2 more
- Volunteers
- 113 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Attain StarFix™ Model 4195 Left Ventricular Lead
People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator.
- Trial name
- NCT00269230
- Testing
- Pacing Lead
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 441 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
- Trial name
- SR-TheAF (NCT05461612)
- Testing
- Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
- Where
- Georgia
- Volunteers
- 30 people
- Sponsor
- Maxwell Biomedical
Heart Failure, Atrial Fibrillation
CONTAK RENEWAL 3 AVT
The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of or at risk of developing atrial and ventricular arrhythmias
- Trial name
- NCT00158977
- Testing
- CONTAK RENEWAL 3 AVT
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Boston Scientific Corporation