Status:
COMPLETED
Safety and Clinical Performance of the Protecta ICD and CRT-D
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Tachyarrhythmias
Heart Failure
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects ...
Detailed Description
The PainFree SST study was a prospective, multicenter clinical trial, which was conducted in two consecutive phases. Phase I assessed safety as determined by assessment of delays in ventricular fibril...
Eligibility Criteria
Inclusion
- Patients meeting one of the following criteria can be included in Phase I of the study:
- Patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (DR-ICD)/cardiac resynchronization therapy defibrillator (CRT-D)
- Patients undergoing a device replacement or upgrade to DR-ICD or CRT-D and with the protocol required leads (patients must be enrolled prior to implant)
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
2770 Patients enrolled
Trial Details
Trial ID
NCT00982397
Start Date
September 1 2009
End Date
September 1 2013
Last Update
November 6 2017
Active Locations (122)
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1
Birmingham Heart Clinic PC
Birmingham, Alabama, United States, 35235
2
CardioVasular Associates of Mesa
Mesa, Arizona, United States, 85206
3
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
4
LA Cardiology Associates
Los Angeles, California, United States, 90017