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OpenTrials
Completed

NCT Number: NCT05621187

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

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

Completed

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachyarrhythmia Tachycardia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Hospital, New Lambton Heights, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pamira ICD lead family

Device

Implantation, measurements and follow-up schedule

Primary outcomes

  1. Pamira lead related SADE-d free rate at 6 months after implantation

    Time frame: 6 months

Secondary outcomes

  1. 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation

    Time frame: 3 months, 12 months

  2. 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up

    Time frame: 6 months, 12 months

  3. 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up

    Time frame: 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

BIO|MASTER.Pamira Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2022
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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