Clinical trial NCT05621187: Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Official title: BIO|MASTER.Pamira Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Tachyarrhythmia
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Pamira lead related SADE-d free rate at 6 months after implantation
timeFrame: 6 months
Secondary outcomes:
measure: 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
timeFrame: 3 months, 12 months
measure: 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
timeFrame: 6 months, 12 months
measure: 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Jette
country: Belgium
facility: UZ Brussels
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
state: Brandenburg
city: Ahaus
country: Germany
facility: St. Marienkrankhaus Klinikum Westmünsterland GmbH
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
state: Sachsen-Anhalt
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben Quedlinburg
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Friedrichstadt
state: Sachsen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
state: Thüringen
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl GmbH
state: Thüringen
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg GmbH
city: Balatonfüred
country: Hungary
facility: State Hospital of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis University
city: Pécs
country: Hungary
facility: The University of Pécs
city: Ashdod
country: Israel
facility: Assuta Medical Center
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek MC
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Banská Bystrica
country: Slovakia
facility: Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.)
Study officials:
affiliation: RHÖN-KLINIKUM Campus Bad Neustadt, Germany
name: Thomas Deneke, Prof.
role: PRINCIPAL_INVESTIGATOR
References: