An observational study in Cardiac Rhythm Disorder, Heart Failure and Sudden Cardiac Death, sponsored by MicroPort CRM. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Observational
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
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:
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients implanted with ENO or ALIZEA family pacing systems
Device: Implantation of a CIED
Patients implanted with ULYS family ICD systems
Device: Implantation of a CIED
Patients implanted with GALI family CRT-D systems
Device: Implantation of a CIED
Implantation of a CIED
Chronic complication free rate of MicroPort CRM market-released system
Complications are defined as device-related reinterventions or deaths
Time frame: Through study duration, an average of 5 years
Acute complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame: Up to 3 months post-implant
Overall complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame: Through study duration, an average of 5 years
Annual complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame: Through study duration, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Jun 2031, 91 months after the start.
Of 69 industry-sponsored observational studies under Arrhythmias, Cardiac, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 51. This study's planned 91 months is above that.
Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.