At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
First ICD/CRT-D implantation or upgrade from pacemakerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TD01 Master Study (Safety and Efficacy Study)
In Brief
An observational study evaluating First ICD/CRT-D implantation or upgrade from pacemaker for ICD/CRT-D Indication. Completed, enrolled 30 participants across 5 sites in 2 countries.
Detailed Summary
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsICD/CRT-D Indication
CountriesAustria, Germany
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartAug 2014
Primary CompletionDec 2015
Study CompletionMar 2020
TodayJul 2026
First PostedMar 14, 2014
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2015
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago
Interventions
First ICD/CRT-D implantation or upgrade from pacemakerdevice