Clinical trials: Defibrillators
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathies, Gender
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the…
- Conditions
- Cardiomyopathies, Gender, Implantable Defibrillator User
- Trial name
- BIO-LIBRA (NCT03884608)
- Where
- 49 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Biotronik, Inc.
Inappropriate Shocks From Implanted Defibrillator, ICD Replacement or Upgrade
Observational Study on Inappropriate Therapies
The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)
- Trial name
- OSIRIS (NCT04118803)
- Testing
- ICD replacement or upgrade
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 881 people
- Sponsor
- MicroPort CRM
Heart Failure, Defibrillators, Implantable
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an…
- Conditions
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy
- Trial name
- PREEMPT-HF (NCT03579641)
- Testing
- HeartLogic Sensors
- Where
- 88 sites in United States, Australia and 11 more
- Volunteers
- 2,184 people
- Sponsor
- Boston Scientific Corporation
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Registry Study of Clinical Application of MRI Compatible CIED
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Trial name
- NCT02380300
- Volunteers
- 2,067 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Complication of Cardiac Defibrillator
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy.
- Trial name
- TARIFF (NCT01075516)
- Where
- 6 sites in Italy
- Volunteers
- 209 people
- Sponsor
- Abbott Medical Devices
Implantable Defibrillator User
Plexa ICD Lead Registry
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
- Trial name
- NCT03103503
- Where
- 28 sites in United States
- Volunteers
- 901 people
- Sponsor
- Biotronik, Inc.
Implantable Defibrillator User
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
- Trial name
- MRI Ready IDE (NCT02787291)
- Testing
- Ellipse VR ICD and Durata/Optisure lead
- Where
- 32 sites in United States, Hungary and 3 more
- Volunteers
- 227 people
- Sponsor
- Abbott Medical Devices
Arrythmia, Implantable Cardioverter Defibrillator
Clinical and Device Functional Assessment of Real World ICD Patients
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF).
- Trial name
- CARAT (NCT02341768)
- Testing
- ICD
- Where
- 102 sites in Austria, Canada and 10 more
- Volunteers
- 2,056 people
- Sponsor
- MicroPort CRM
Implantable Defibrillator User
Protego DF4 Post Approval Registry
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
- Trial name
- NCT02243696
- Where
- 68 sites in United States
- Volunteers
- 1,694 people
- Sponsor
- Biotronik, Inc.
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
- Trial name
- REACT (NCT01090349)
- Testing
- Implantation of an ICD/CRT-D device, Merlin.NET PCN
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 220 people
- Sponsor
- Abbott Medical Devices
Implantable Defibrillator
Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI…
- Trial name
- NCT02117414
- Testing
- MRI scan sequences of the head and chest regions, Waiting Period Visit
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 275 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
ProMRI Study of the Iforia ICD System (Phase C)
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
- Trial name
- NCT02096692
- Testing
- Patients with a ProMRI ICD System, Magnetic Resonance Imaging (MRI) scan
- Where
- 39 sites in United States
- Volunteers
- 154 people
- Sponsor
- Biotronik, Inc.
Defibrillators, Tachycardia
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring…
- Trial name
- Educ@t (NCT01006746)
- Testing
- Remote monitoring by Home Monitoring system
- Where
- France
- Volunteers
- 571 people
- Sponsor
- Biotronik France
Arrhythmias, Cardiac, Heart Diseases
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter…
- Conditions
- Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator
- Trial name
- SHIELD-2 (NCT01464476)
- Testing
- Azimilide Dihydrochloride
- Where
- 138 sites in United States, Belgium and 11 more
- Volunteers
- 240 people
- Sponsor
- Forest Laboratories