This trial is active, not recruiting.

Condition icd/crt-d indication
Treatment first icd/crt-d implantation or upgrade from pacemaker
Sponsor Biotronik SE & Co. KG
Start date August 2014
End date December 2015
Trial size 44 participants
Trial identifier NCT02087189, TA107


This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
first icd/crt-d implantation or upgrade from pacemaker TD01 (investigational device)

Primary Outcomes

Pacing threshold with TD01
time frame: 3 month follow-up
Sensing amplitude with TD01
time frame: 3 month follow-up

Secondary Outcomes

SADE-free rate related to TD01
time frame: 3 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Meet standard indication for ICD/CRT-D therapy - First ICD/CRT-D implantation or upgrade from pacemaker - Duly signed informed consent form - Willing to participate for the whole study duration - Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger - Patient has a legal capacity and ability to consent Exclusion Criteria: - Meet a standard contraindication for an ICD/CRT-D therapy - Age < 18 years - Pregnant or breast-feeding - Cardiac surgery planned within the next six months - Enrollment in another cardiac clinical investiga-tion with active treatment arm - Mechanical tricuspid valve prosthesis or severe tricuspid valve disease - Known dexamethasone acetate intolerance

Additional Information

Official title TD01 Master Study (Safety and Efficacy Study)
Principal investigator Oliver Gunkel, Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Biotronik SE & Co. KG.