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

NCT05621187 | Completed

• 1 other identifier: TA117
• Study Type: interventional
• Target: 221
• Locations: 7 countries
• Sites: 22

Brief 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

Heart Failure; Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

All patients

OTHER

Device: Pamira ICD lead family

Interventions

Pamira ICD lead family DEVICE

Implantation, measurements and follow-up schedule

All patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (23)

John Hunter Hospital

New Lambton Heights, New South Wales, NSW 2305, Australia

Location

Medizinische Universität Graz

Graz, Styria, Austria

Location

UZ Brussels

Jette, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, Belgium

Location

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Location

Klinikum der Universität München

München, Bavaria, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau bei Berlin, Brandenburg, Germany

Location

St. Marienkrankhaus Klinikum Westmünsterland GmbH

Ahaus, North Rhine-Westphalia, Germany

Location

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, Saxony, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Location

Klinikum Dorothea Christiane Erxleben Quedlinburg

Quedlinburg, Saxony-Anhalt, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, Thuringia, Germany

Location

SRH Zentralklinikum Suhl GmbH

Suhl, Thuringia, Germany

Location

Städtisches Klinikum Brandenburg GmbH

Brandenburg, Germany

Location

State Hospital of Cardiology

Balatonfüred, Hungary

Location

Semmelweis University

Budapest, Hungary

Location

The University of Pécs

Pécs, Hungary

Location

Assuta Medical Center

Ashdod, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Shaare Zedek MC

Jerusalem, Israel

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.)

Banská Bystrica, Slovakia

Location

MeSH Terms

Conditions

Heart Failure; Tachycardia

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Deneke, Prof.

  RHÖN-KLINIKUM Campus Bad Neustadt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 17, 2022
• Study Start: November 30, 2022
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); IL (3); SL (1); LA (1); HU (3); DE (11); BE (2)