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

Heart Failure Clinical Trial

Official title:

BIO|MASTER.Pamira Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05621187
• Other study ID #: TA117
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 221
• Est. completion date: February 28, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmia
• Tachycardia

Intervention

Device:
• Pamira ICD lead family
Implantation, measurements and follow-up schedule

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pamira lead related SADE-d free rate at 6 months after implantation		6 months
Secondary	1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation		3 months, 12 months
Secondary	2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up		6 months, 12 months
Secondary	3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up		6 months, 12 months