← Back to all trials
Recruiting
NCT05621187
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Conditions: Heart Failure, Tachyarrhythmia
Sex: All
Ages: 18 Years – 99 Years
Phase: NA
Enrollment: 218
Sponsor: Biotronik SE & Co. KG
Location: Australia
Summary
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims bydemonstrating clinical safetyevaluating performance based on sensing and pacing assessmentcollecting additional data of interest to assess other aspects such as the handling and usability
Eligibility Criteria
Inclusion Criteria:Standard indication for ICD or CRT-D therapy according to clinical guidelinesPlanned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with PamiraAbility to understand the nature of the study and willingness to provide written informed consentAbility and willingness to perform all follow-up visits at the study siteAbility and willingness to use the CardioMessenger and acceptance the BIOTRONIK Home Monitoring® conceptExclusion Criteria:Mechanical tricuspid valve prosthesis or a severe tricuspid valve diseaseKnown Dexamethasone acetate intoleranceCardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)Less than 18 years oldPregnant or breast feedingParticipating in another interventional clinical investigationLife-expectancy less than 12 months
Source: ClinicalTrials.gov (NCT05621187). StuddyBuddy aggregates publicly available trial information.