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

BIO|MASTER.Pamira Study

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Tachyarrhythmia
• Intervention / Treatment: Device: Pamira ICD lead family

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, NSW 2305
      • John Hunter Hospital
• Austria
  • Steiermark
    • Graz, Steiermark, Austria
      • Medizinische Universität Graz
• Belgium
  • Jette, Belgium
    • UZ Brussels
  • Leuven, Belgium
    • UZ Leuven Gasthuisberg
• Germany
  • Brandenburg, Germany
    • Städtisches Klinikum Brandenburg GmbH
  • Bayern
    • Erlangen, Bayern, Germany
      • Universitätsklinikum Erlangen
    • München, Bayern, Germany
      • Klinikum der Universität München
    • Würzburg, Bayern, Germany
      • Universitätsklinikum Würzburg
  • Brandenburg
    • Bernau, Brandenburg, Germany
      • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Nordrhein-Westfalen
    • Ahaus, Nordrhein-Westfalen, Germany
      • St. Marienkrankhaus Klinikum Westmünsterland GmbH
  • Sachsen
    • Dresden, Sachsen, Germany
      • Städtisches Klinikum Dresden-Friedrichstadt
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany
      • Otto-von-Guericke-Universität Magdeburg
    • Quedlinburg, Sachsen-Anhalt, Germany
      • Klinikum Dorothea Christiane Erxleben Quedlinburg
  • Thüringen
    • Gera, Thüringen, Germany
      • SRH Wald-Klinikum Gera GmbH
    • Suhl, Thüringen, Germany
      • SRH Zentralklinikum Suhl GmbH
• Hungary
  • Balatonfüred, Hungary
    • State Hospital of Cardiology
  • Budapest, Hungary
    • Semmelweis University
  • Pécs, Hungary
    • The University of Pécs
• Israel
  • Ashdod, Israel
    • Assuta Medical Center
  • Beer-Sheva, Israel
    • Soroka Medical Center
  • Jerusalem, Israel
    • Shaare Zedek MC
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• Slovakia
  • Banská Bystrica, Slovakia
    • Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All patients	Device: Pamira ICD lead family; Implantation, measurements and follow-up schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pamira lead related SADE-d free rate at 6 months after implantation	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation	3 months, 12 months
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up	6 months, 12 months
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up	6 months, 12 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Thomas Deneke, Prof., RHÖN-KLINIKUM Campus Bad Neustadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia
• Other Study ID Numbers: TA117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No