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

NCT05621187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2025-02-26

No results posted yet for this study

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 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

Conditions

Interventions

DEVICE

Pamira ICD lead family

Implantation, measurements and follow-up schedule

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Thomas Deneke, Prof. · RHÖN-KLINIKUM Campus Bad Neustadt, Germany

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2025-01-20
Completion
2025-01-20

Countries

  • Australia
  • Austria
  • Belgium
  • Germany
  • Hungary
  • Israel
  • Latvia
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05621187 on ClinicalTrials.gov