Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

Biotronik

Status: Completed

Conditions: Heart Failure; Tachyarrhythmia

Treatments: Device: Pamira ICD lead family

Study type: Interventional

Funder types: Industry

Identifiers

NCT05621187

TA117

Details and patient eligibility

About

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 by

• demonstrating clinical safety
• evaluating performance based on sensing and pacing assessment
• collecting additional data of interest to assess other aspects such as the handling and usability

Enrollment: 221 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Standard indication for ICD or CRT-D therapy according to clinical guidelines
• Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira
• Ability to understand the nature of the study and willingness to provide written informed consent
• Ability and willingness to perform all follow-up visits at the study site
• Ability and willingness to use the CardioMessenger and acceptance the BIOTRONIK Home Monitoring® concept

Exclusion criteria

• Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
• Known Dexamethasone acetate intolerance
• Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
• Less than 18 years old
• Pregnant or breast feeding
• Participating in another interventional clinical investigation
• Life-expectancy less than 12 months

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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221 participants in 1 patient group

All patients

Other group

Treatment:

Device: Pamira ICD lead family