Pacemaker DDDNCT04323670
Master Study Investigating the Guiding Catheter Selectra 3D
A study testing "Selectra 3D" guiding catheter in people with Pacemaker DDD, run by Biotronik SE & Co. KG at 1 site in France.
Trial summary
Study investigating the guiding catheter Selectra 3D Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pacemaker DDD
- What is being tested?
- "Selectra 3D" guiding catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2020to 22 Dec 2022
- 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 de novo pacemaker or cardiac resynchronization implantation
- The patient is intended for guiding catheter based implantation of a pacemaker system
- Patient is able to understand the nature of the study and has provided written informed consent
- Patient is willing and able to perform all follow up visits at the study site
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring® concept
Who cannot join
- AV block with no escape rhythm or broad QRS escape rhythm
- Standard contraindications for use of the investigational devices:
- Existing or possible occlusion of the coronary vessels or unsuitable anatomy of the coronary veins
- Active systemic infection
- Mechanical tricuspid valve prosthesis or severe tricuspid valve diseases
- Intolerance against dexamethasone acetate
Show all 12Show fewer
- Planned cardiac surgical procedures or interventional measures in addition to the study procedure within the next 6 months
- Expected to receive heart transplantation or ventricular assist device within 1 year
- Patient is pregnant or breast feeding
- Less than 18 years old
- Participating in another interventional clinical investigation
- Life-expectancy is less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIO|MASTER.Selectra 3D Study
Study investigating the guiding catheter Selectra 3D
Read the detailed description
The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area.
This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation.
- Conditions
- Pacemaker DDD
- Being tested
- "Selectra 3D" guiding catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Selectra 3D" guiding catheterDevice
His lead measurements
| Study group | Role | What they receive |
|---|---|---|
| Selectra 3D | Other | Guiding catheter to position the brady lead into a untypical heart position Receives: Device: "Selectra 3D" guiding catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selectra 3D-related SADE-free rate
Selectra 3D-related Serious adverse device effect rate
Measured: 7 days after implantation
Secondary outcomes (4)
Successful implantation rate
Assessment, if the pacemaker lead is positioned successfully in the intended target position
Measured: At the day of implantation
Appropriateness of sensing and pacing of Solia S
Investigator assessment for leads in His position
Measured: 12 months
SADE-free rate of Solia S
Safety of Solia S in His position
Measured: 6 months
SADE-free rate of Solia S
Safety of Solia S in His position
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start8 Oct 2020
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DDDStudies 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
- Model description
- Guiding catheter Selectra 3D
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwais Mohamed, PhD, Principal investigator, The Northern Hospital, Epping, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323670
- Sponsor's protocol ID
- BA110
- Status last verified
- May 2022
- First submitted
- 17 Mar 2020
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|MASTER.Selectra 3D Study
- ClinicalTrials.gov ID
- NCT04323670
- Acronym / sponsor ID
- BA110
- Conditions
- Pacemaker DDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 26 Mar 2020 (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.
Study investigating the guiding catheter Selectra 3D
Detailed description
The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area.
This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Guiding catheter Selectra 3D
| Arm | Type | Receives |
|---|---|---|
| Selectra 3D | Other | Device: "Selectra 3D" guiding catheterGuiding catheter to position the brady lead into a untypical heart position |
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 de novo pacemaker or cardiac resynchronization implantation
- The patient is intended for guiding catheter based implantation of a pacemaker system
- Patient is able to understand the nature of the study and has provided written informed consent
- Patient is willing and able to perform all follow up visits at the study site
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring® concept
Key exclusion criteria (12 listed)
- AV block with no escape rhythm or broad QRS escape rhythm
- Standard contraindications for use of the investigational devices:
- Existing or possible occlusion of the coronary vessels or unsuitable anatomy of the coronary veins
- Active systemic infection
- Mechanical tricuspid valve prosthesis or severe tricuspid valve diseases
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 |
|---|---|---|
| "Selectra 3D" guiding catheterHis lead measurements | Device | Selectra 3D |
Primary outcome
Selectra 3D-related SADE-free rate
Time frame: 7 days after implantation
Selectra 3D-related Serious adverse device effect rate
4 secondary outcomes
Successful implantation rate
Time frame: At the day of implantation
Appropriateness of sensing and pacing of Solia S
Time frame: 12 months
SADE-free rate of Solia S
Time frame: 6 months
SADE-free rate of Solia S
Time frame: 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 3 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Uwais Mohamed, PhD principal investigator
The Northern Hospital, Epping, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Selectra 3D" guiding catheter in people with Pacemaker DDD, run by Biotronik SE & Co. KG at 1 site in France.
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 12 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Selectra 3D-related SADE-free rate (time frame: 7 days after implantation). 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 3 Mar 2023.