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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05621187




Registration number
NCT05621187
Ethics application status
Date submitted
7/11/2022
Date registered
17/11/2022
Date last updated
30/01/2024

Titles & IDs
Public title
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Scientific title
BIO|MASTER.Pamira Study
Secondary ID [1] 0 0
TA117
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Tachyarrhythmia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pamira ICD lead family

Other: All patients -

Experimental: Male patients with hormone sensitive disease - who demonstrate rising PSA levels (\>0.2ng/ml) following definitive therapy and a negative 68Ga-PSMA-11 PET scan (defined as SUV max \< 3);


Treatment: Devices: Pamira ICD lead family
Implantation, measurements and follow-up schedule
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Deneke, Prof.
Address 0 0
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05621187