Study to Evaluate System Safety and Clinical Performance of the Protecta Implantable Cardioverter Defibrillator (ICD) Plus Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Conditions
- Health Condition 1: null- TachyarrhythmiasHeart FailureVentricular Dysfunction
- Registration Number
- CTRI/2010/091/000657
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2000
Patients meeting one of the following criteria can be included in Phase II of the study:
Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a Protecta device
Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade to a Protecta DR-ICD/VR-ICD or CRT-D
Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta device and the protocol required leads, who have not yet been discharged after implant
Patients with a mechanical tricuspid heart valve
Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc)
Patients anticipated not being able to complete the study
Patients unwilling to provide written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method