Clinical trials: Implantable Defibrillator User
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
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.
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.
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 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.