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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Other: All patients -


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
Primary outcome [1] 0 0
Pamira lead related SADE-d free rate at 6 months after implantation
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
Timepoint [1] 0 0
3 months, 12 months
Secondary outcome [2] 0 0
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
Timepoint [2] 0 0
6 months, 12 months
Secondary outcome [3] 0 0
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Timepoint [3] 0 0
6 months, 12 months

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
N/A
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)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
NSW 2305 - New Lambton Heights
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Steiermark
Country [2] 0 0
Belgium
State/province [2] 0 0
Jette
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Germany
State/province [4] 0 0
Bayern
Country [5] 0 0
Germany
State/province [5] 0 0
Brandenburg
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein-Westfalen
Country [7] 0 0
Germany
State/province [7] 0 0
Sachsen-Anhalt
Country [8] 0 0
Germany
State/province [8] 0 0
Sachsen
Country [9] 0 0
Germany
State/province [9] 0 0
Thüringen
Country [10] 0 0
Hungary
State/province [10] 0 0
Balatonfüred
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Hungary
State/province [12] 0 0
Pécs
Country [13] 0 0
Israel
State/province [13] 0 0
Ashdod
Country [14] 0 0
Israel
State/province [14] 0 0
Beer-Sheva
Country [15] 0 0
Israel
State/province [15] 0 0
Jerusalem
Country [16] 0 0
Latvia
State/province [16] 0 0
Riga
Country [17] 0 0
Slovakia
State/province [17] 0 0
Banská Bystrica

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

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05621187
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