Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
BIO|MASTER.Pamira Study
Query!
Secondary ID [1]
0
0
TA117
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Failure
0
0
Query!
Tachyarrhythmia
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Pamira lead related SADE-d free rate at 6 months after implantation
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
6 months
Query!
Secondary outcome [1]
0
0
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
3 months, 12 months
Query!
Secondary outcome [2]
0
0
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
6 months, 12 months
Query!
Secondary outcome [3]
0
0
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
6 months, 12 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/11/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/02/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
221
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
John Hunter Hospital - New Lambton Heights
Query!
Recruitment postcode(s) [1]
0
0
NSW 2305 - New Lambton Heights
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Steiermark
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Jette
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Leuven
Query!
Country [4]
0
0
Germany
Query!
State/province [4]
0
0
Bayern
Query!
Country [5]
0
0
Germany
Query!
State/province [5]
0
0
Brandenburg
Query!
Country [6]
0
0
Germany
Query!
State/province [6]
0
0
Nordrhein-Westfalen
Query!
Country [7]
0
0
Germany
Query!
State/province [7]
0
0
Sachsen-Anhalt
Query!
Country [8]
0
0
Germany
Query!
State/province [8]
0
0
Sachsen
Query!
Country [9]
0
0
Germany
Query!
State/province [9]
0
0
Thüringen
Query!
Country [10]
0
0
Hungary
Query!
State/province [10]
0
0
Balatonfüred
Query!
Country [11]
0
0
Hungary
Query!
State/province [11]
0
0
Budapest
Query!
Country [12]
0
0
Hungary
Query!
State/province [12]
0
0
Pécs
Query!
Country [13]
0
0
Israel
Query!
State/province [13]
0
0
Ashdod
Query!
Country [14]
0
0
Israel
Query!
State/province [14]
0
0
Beer-Sheva
Query!
Country [15]
0
0
Israel
Query!
State/province [15]
0
0
Jerusalem
Query!
Country [16]
0
0
Latvia
Query!
State/province [16]
0
0
Riga
Query!
Country [17]
0
0
Slovakia
Query!
State/province [17]
0
0
Banská Bystrica
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Biotronik SE & Co. KG
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05621187
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Thomas Deneke, Prof.
Query!
Address
0
0
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05621187
Download to PDF