Last updated on January 2015

Protego DF4 Post Approval Registry


Brief description of study

Protego DF4 Post Approval Registry

Detailed Study Description

The purpose of this post-approval registry is to confirm the safety and reliability of the Protego lead as used in conjunction with any compatible BIOTRONIK Ilesto or future US market released DF4 ICD or CRT-D device. Data will be collected from up to 1694 subjects from implant through 5 years of follow-up.

Subjects eligible for the registry include those that will be implanted with a Protego lead within the 30 days following enrollment procedures or have been implanted with a Protego lead within 30 days of enrollment. Prior to enrollment procedures, subjects will be screened to ensure eligibility and will sign an informed consent. Consent and enrollment must occur at a maximum of 30 days prior to or post implant of the Protego lead.

Safety will be evaluated based on the analysis of all Protego lead and device header related adverse events. Acute and chronic lead parameters for sensing, pacing thresholds, and pacing and shock impedance will be evaluated for the Protego lead.

Additionally, acute and chronic lead parameters for sensing, pacing thresholds, and pacing impedance will be evaluated for all BIOTRONIK leads, including right atrial and left ventricular leads.

All devices included in the registry are legally marketed and prescribed by physicians according to approved indications for use.

Clinical Study Identifier: TX5265

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Melissa Shepherd

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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