BradycardiaPhase 4CAPRINCT03811691
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
A Phase 4 study testing MRI exam in people with Bradycardia, run by MicroPort CRM at 1 site in France.
Trial summary
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bradycardia
- What is being tested?
- MRI exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2019to Aug 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who meet all the following criteria at the time of inclusion visit may be included:
- Already implanted in the left or right pectoral region for at least 6 weeks with:
- ENO, TEO or OTO single chamber rate response (SR) pacemaker with a VEGA pacing lead, or
- ENO, TEO or OTO dual chamber rate response (DR) pacemaker with two VEGA pacing leads.
- Implanted pacing system must fulfill the following parameters:
- Battery impedance is < 5 Kilo Ohm (kΩ)
Show all 23Show fewer
- Pacing capture threshold value is ≤ 2 Volts (V) at 0.35 millisecond (ms)
- Lead impedance value between 200Ω and 3000Ω
- No diaphragmatic or pectoral stimulation at 5V/1ms
- P-wave minimum sensed amplitude ≥ 1mV for patients with sinus rhythm
- R-wave minimum sensed amplitude ≥ 4mV for patients with spontaneous conduction rhythm
- Must agree to undergo a non clinically-indicated MRI scan without intravenous injection and without sedation;
- Have reviewed, signed and dated informed consent.
- Subjects who meet any of the following criteria are not eligible to be included in the study:
- Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device;
- Have other active or abandoned cardiac implants already implanted;
- Have other active or passive non MR conditional devices implanted such as metallic foreign body;
- Have a history of brain aneurysm with ferromagnetic clipping;
- Have a planned cardiac surgery within the 3 months of inclusion;
- Have a medical MRI examination prescription planned within the 3 months of inclusion;
- Age less than 18 years old or under guardianship or kept in detention;
- Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method ;
- Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
MicroPort CRM
Clamart, Haut de Seine, 92140
Anne RousseauPlasse, 01 46 01 30 82 ext. +33, Anne.RousseauPlasse@crm.microport.com
About this study
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline.
Read the detailed description
The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s). Conditions to undergo an MRI scan are provided in the MRI solutions guideline.
The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.
The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan:
- Stability of the Pacing Capture Threshold
- Stability of the lead sensed amplitude
- Conditions
- Bradycardia
- Being tested
- MRI exam
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examDiagnostic test
Pacing system safety and stability under MRI scan environment
| Study group | Role | What they receive |
|---|---|---|
| 1.5 Tesla MRI Scan | Other | Subjects will undergo 1.5T MRI exam Receives: Diagnostic Test: MRI exam |
| 3 Tesla MRI Scan | Other | Subjects will undergo 3T MRI exam Receives: Diagnostic Test: MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication.
The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Measured: 1 month post MRI
Secondary outcomes (4)
Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan
Subject's ventricular pacing capture threshold will be measured in Volt (V) at 0.5ms at baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Measured: 1 month post MRI
Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan
Subject's atrial pacing capture threshold will be measured in Volt (V) at 0.5ms at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Measured: 1 month post MRI
Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan
Subject's ventricular minimum sensed amplitude will be measured in mV at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as 50% or less decrease between the two visits. If subject's ventricular minimum sensed amplitude is less or equal to 4mV at time of baseline, then this subject will not count for this endpoint. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Measured: 1 month post MRI
Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan
Subject's atrial minimum sensed amplitude will be measured in mV at baseline. A success is defined as 50% or less decrease between the two visits. If subject's atrial minimum sensed amplitude is less or equal to 1mV at time of Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit, then this subject will not count for this endpoint.The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Measured: 1 month post MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start18 Jul 2019
- Primary completionDec 2021 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811691
- Sponsor's protocol ID
- IBSY06 - CAPRI
- Acronym
- CAPRI
- Status last verified
- Jun 2021
- First submitted
- 15 Jan 2019
- Last updated
- 9 Jun 2021
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
- ClinicalTrials.gov ID
- NCT03811691
- Acronym / sponsor ID
- CAPRI / IBSY06 - CAPRI
- Conditions
- Bradycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 22 Jan 2019 (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.
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline.
Detailed description
The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s). Conditions to undergo an MRI scan are provided in the MRI solutions guideline.
The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.
The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan:
- Stability of the Pacing Capture Threshold
- Stability of the lead sensed amplitude
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.
| Arm | Type | Receives |
|---|---|---|
| 1.5 Tesla MRI Scan | Other | Diagnostic Test: MRI examSubjects will undergo 1.5T MRI exam |
| 3 Tesla MRI Scan | Other | Diagnostic Test: MRI examSubjects will undergo 3T MRI exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects who meet all the following criteria at the time of inclusion visit may be included:
- Already implanted in the left or right pectoral region for at least 6 weeks with:
- Implanted pacing system must fulfill the following parameters:
- Must agree to undergo a non clinically-indicated MRI scan without intravenous injection and without sedation;
- Have reviewed, signed and dated informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MRI examPacing system safety and stability under MRI scan environment | Diagnostic test | 1.5 Tesla MRI Scan, 3 Tesla MRI Scan |
Primary outcome
Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
Time frame: 1 month post MRI
An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication. The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
4 secondary outcomes
Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan
Time frame: 1 month post MRI
Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan
Time frame: 1 month post MRI
Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan
Time frame: 1 month post MRI
Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan
Time frame: 1 month post MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MRI exam in people with Bradycardia, run by MicroPort CRM 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 23 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne RousseauPlasse (01 46 01 30 82 ext. +33, Anne.RousseauPlasse@crm.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system (time frame: 1 month post MRI). 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 9 Jun 2021.