Overview

This trial is active, not recruiting.

Conditions ventricular tachycardia, ventricular fibrillation, heart failure
Treatment sd01 icd lead
Sponsor Biotronik SE & Co. KG
Start date May 2013
End date October 2019
Trial size 160 participants
Trial identifier NCT01836497, 62

Summary

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Rate of appropriate sensing and pacing
time frame: at the 3-month follow-up
Serious adverse device effects (SADEs) related to the SD01 lead
time frame: until the 3-month follow-up

Secondary Outcomes

Measure
Comparison of pacing threshold between Linoxsmart and SD01
time frame: at the 3-month follow-up
Shift rate of the painless shock impedance measurement
time frame: between 3- and 6-month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Standard indication for an ICD/CRT-D therapy - Signed informed consent form - Patient is willing and able to participate for the whole study duration - Patient is willing and able to activate and use the CardioMessenger - Legal capacity and ability to consent. Exclusion Criteria: - Standard contraindication for an ICD/CRT-D therapy - Age <18 years. - Pregnant or breastfeeding - Cardiac surgery is planned within the next six months - Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period - Enrollment in another cardiac clinical investigation with active treatment arm - Mechanical tricuspid valve prosthesis or severe tricuspid valve disease - Dexamethasone acetate intolerance

Additional Information

Official title SD01 Master Study (Safety and Efficacy Study)
Principal investigator Frank Bode, PD Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Biotronik SE & Co. KG.