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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05621187). StuddyBuddy aggregates publicly available trial information.