Cardiac Rhythm DisorderPIANONCT05694572
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
An observational study of Cardiac Rhythm Disorder and Heart Failure, run by MicroPort CRM at 1 site in Portugal.
Trial summary
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
- What is being tested?
- Implantation of a CIED
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Oct 2023to 15 Jun 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects implanted with a pacemaker, an Implantable Cardioverter-Defibrillator (ICD) or a Cardiac Resynchronization Therapy (CRT-D) Class I or II indication according to the latest guidelines from the European Society of Cardiology (ESC)1 or from the American College of Cardiology (ACC)/ American Heart Association (AHA)/ Heart Rhythm society (HRS)2 as appropriate per geography.
Who may be able to join
- Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:
- Subject implanted with one of the following MicroPort CRM market-released system:
- ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead
- ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.
- GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.
- GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.
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- Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead
- Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
- Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
- Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation
Who cannot join
- Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
- Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
- Life expectancy less than 1 year
- Currently enrolled in an active study of MicroPort CRM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Santa Marta Lisboa
Lisbon
Mario Olivera, MD
About this study
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
Read the detailed description
PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market and released since 2018.
Continuous monitoring of MicroPort CRM market-released systems will also enable to:
- confirm the safety and performance of the device throughout the study duration
- identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
- identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio
- identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct
- Conditions
- Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
- Being tested
- Implantation of a CIED
- Medical subject headings
- Arrhythmias, Cardiac, Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a CIEDDevice
Implantation of a CIED
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker system | Patients implanted with ENO or ALIZEA family pacing systems Receives: Device: Implantation of a CIED | |
| ICD system | Patients implanted with ULYS family ICD systems Receives: Device: Implantation of a CIED | |
| CRT-D system | Patients implanted with GALI family CRT-D systems Receives: Device: Implantation of a CIED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic complication free rate of MicroPort CRM market-released system
Complications are defined as device-related reinterventions or deaths
Measured: Through study duration, an average of 5 years
Secondary outcomes (3)
Acute complication free rate
Complications are defined as device-related reinterventions or deaths
Measured: Up to 3 months post-implant
Overall complication free rate
Complications are defined as device-related reinterventions or deaths
Measured: Through study duration, an average of 5 years
Annual complication free rate
Complications are defined as device-related reinterventions or deaths
Measured: Through study duration, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start30 Oct 2023
- Primary completion15 Jun 2031 (estimated)
- Study completion15 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Rhythm DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yann POEZEVARA, MSc, Study director, MicroPort CRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694572
- Sponsor's protocol ID
- LMIO01
- Acronym
- PIANO
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT05694572
- Acronym / sponsor ID
- PIANO / LMIO01
- Conditions
- Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 15 Jun 2031 (estimated)
- Study completion
- 15 Jun 2031 (estimated)
- First posted
- 23 Jan 2023 (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 primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
Detailed description
PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market and released since 2018.
Continuous monitoring of MicroPort CRM market-released systems will also enable to:
- confirm the safety and performance of the device throughout the study duration
- identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
- identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio
- identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pacemaker system | – | Device: Implantation of a CIEDPatients implanted with ENO or ALIZEA family pacing systems |
| ICD system | – | Device: Implantation of a CIEDPatients implanted with ULYS family ICD systems |
| CRT-D system | – | Device: Implantation of a CIEDPatients implanted with GALI family CRT-D systems |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects implanted with a pacemaker, an Implantable Cardioverter-Defibrillator (ICD) or a Cardiac Resynchronization Therapy (CRT-D) Class I or II indication according to the latest guidelines from the European Society of Cardiology (ESC)1 or from the American College of Cardiology (ACC)/ American Heart Association (AHA)/ Heart Rhythm society (HRS)2 as appropriate per geography.
Key inclusion criteria (10 listed)
- Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:
- Subject implanted with one of the following MicroPort CRM market-released system:
- Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
- Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
- Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation
Key exclusion criteria (4 listed)
- Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
- Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
- Life expectancy less than 1 year
- Currently enrolled in an active study of MicroPort CRM
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 |
|---|---|---|
| Implantation of a CIEDImplantation of a CIED | Device | CRT-D system, ICD system, Pacemaker system |
Primary outcome
Chronic complication free rate of MicroPort CRM market-released system
Time frame: Through study duration, an average of 5 years
Complications are defined as device-related reinterventions or deaths
3 secondary outcomes
Acute complication free rate
Time frame: Up to 3 months post-implant
Overall complication free rate
Time frame: Through study duration, an average of 5 years
Annual complication free rate
Time frame: Through study duration, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yann POEZEVARA, MSc study director
MicroPort CRM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rhythm Disorder and Heart Failure, run by MicroPort CRM at 1 site in Portugal.
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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jan 2024. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanan FAWAZ, MSC (33616531960, hanan.fawaz@crm.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic complication free rate of MicroPort CRM market-released system (time frame: Through study duration, an average of 5 years). 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 17 Jan 2024.