Heart FailureNCT05621187
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
A study testing Pamira ICD lead family in people with Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 23 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Tachyarrhythmia
- What is being tested?
- Pamira ICD lead family
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 30 Nov 2022to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Germany11 sites
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus, North Rhine-Westphalia
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg
Städtisches Klinikum Brandenburg GmbH
Brandenburg
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Saxony
Universitätsklinikum Erlangen
Erlangen, Bavaria
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Saxony-Anhalt
Klinikum der Universität München
München, Bavaria
Klinikum Dorothea Christiane Erxleben Quedlinburg
Quedlinburg, Saxony-Anhalt
SRH Zentralklinikum Suhl GmbH
Suhl, Thuringia
Universitätsklinikum Würzburg
Würzburg, Bavaria
Hungary3 sites
State Hospital of Cardiology
Balatonfüred
Semmelweis University
Budapest
The University of Pécs
Pécs
Israel3 sites
Assuta Medical Center
Ashdod
Soroka Medical Center
Beersheba
Shaare Zedek MC
Jerusalem
Australia1 site
John Hunter Hospital
New Lambton Heights, New South Wales, NSW 2305
Slovakia1 site
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. (SÚSCCH, a.s.)
Banská Bystrica
About this study
Official title: BIO|MASTER.Pamira Study
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
- Conditions
- Heart Failure, Tachyarrhythmia
- Being tested
- Pamira ICD lead family
- Medical subject headings
- Heart Failure, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pamira ICD lead familyDevice
Implantation, measurements and follow-up schedule
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Not described Receives: Device: Pamira ICD lead family |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pamira lead related SADE-d free rate at 6 months after implantation
Measured: 6 months
Secondary outcomes (3)
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
Measured: 3 months, 12 months
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
Measured: 6 months, 12 months
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start30 Nov 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Deneke, Prof., Principal investigator, RHÖN-KLINIKUM Campus Bad Neustadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621187
- Sponsor's protocol ID
- TA117
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|MASTER.Pamira Study
- ClinicalTrials.gov ID
- NCT05621187
- Acronym / sponsor ID
- TA117
- Conditions
- Heart Failure, Tachyarrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Device: Pamira ICD lead family |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pamira ICD lead familyImplantation, measurements and follow-up schedule | Device | All patients |
Primary outcome
Pamira lead related SADE-d free rate at 6 months after implantation
Time frame: 6 months
3 secondary outcomes
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
Time frame: 3 months, 12 months
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
Time frame: 6 months, 12 months
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Time frame: 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Deneke, Prof. principal investigator
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pamira ICD lead family in people with Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Hungary, Israel, Belgium, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pamira lead related SADE-d free rate at 6 months after implantation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.