SD01 Master Study (Safety and Efficacy Study)

Biotronik SE & Co. KG14 sites in 5 countries163 target enrollmentMay 2013

ConditionsVentricular Tachycardia Ventricular Fibrillation Heart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ventricular Tachycardia
Sponsor: Biotronik SE & Co. KG
Enrollment: 163
Locations: 14
Primary Endpoint: Rate of appropriate sensing and pacing
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

September 25, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of appropriate sensing and pacing

Time Frame: at the 3-month follow-up

The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of 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

Comparison of pacing threshold between Linoxsmart and SD01(at the 3-month follow-up)
Shift rate of the painless shock impedance measurement(between 3- and 6-month follow-up)