Safety and Clinical Performance of the Protecta ICD and CRT-D

Completed · Not applicable

Conditions studied: Tachyarrhythmias, Heart Failure, Ventricular Dysfunction

In brief

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 implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.

Key facts

Study ID

NCT00982397

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

2770

Starts

2009-09-01

Expected to finish

2013-09-01

Last updated by the study team

2017-11-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CardioVasular Associates of Mesa — Mesa, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• LA Cardiology Associates — Los Angeles, California, United States
• Cardiology Consultants of Napa Valley — Napa, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• University of Florida Health at Jacksonville — Jacksonville, Florida, United States
• Arrhythmia Syncope Consultants LLC — Miami, Florida, United States
• Indiana Heart Physicians — Indianapolis, Indiana, United States
• Cardiovascular Research of Northwest Indiana — Munster, Indiana, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Delmarva Heart Research Foundation — Salisbury, Maryland, United States
• Essentia Institute of Rural Health — Duluth, Minnesota, United States
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
• Saint John's Medical Research Inc — Springfield, Missouri, United States
• Saint Louis Heart & Vascular PC — St Louis, Missouri, United States
• Cardiology PC — Syracuse, New York, United States
• Pinehurst Medical Clinic — Pinehurst, North Carolina, United States
• Ohio Heart and Vascular — Cincinnati, Ohio, United States
• St. Vincent Mercy Medical Center — Toledo, Ohio, United States
• Central Bucks Cardiology — Doylestown, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Pee Dee Cardiology — Florence, South Carolina, United States
• Cardiology Consultants PA — Spartanburg, South Carolina, United States
• Centennial Heart Cardiovascular Consultants LLC — Nashville, Tennessee, United States
• Birmingham Heart Clinic PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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