Block Complete Hearti-LEAPERNCT05528029
International Ledless Pacemaker Registry
An observational study of Block Complete Heart and Atrial Fibrillation, run by Luigi Sacco University Hospital at 12 sites in 3 countries.
Trial summary
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Block Complete Heart, Atrial Fibrillation
- What is being tested?
- Leadless Pacemaker (Micra)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Italy10 sites, 10 recruiting
- Recruiting
Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)
Ancona
Antonio Dello Russo, MD, PhD, antonio.dellorusso@gmail.com
Antonio Dello Russo, MD
- Recruiting
Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola
Bologna
Mauro Biffi, MD, mbiffi64@gmail.com
Mauro Biffi, MD
- Recruiting
Spedali Civili di Brescia
Brescia, 25123
Antonio Curnis, MD, +390303995552, antonio.curnis@unibs.it
- Recruiting
Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)
Lecce
Ennio Pisanò, MD, enniopisano@hotmail.com
Ennio Pisanò, MD
- Recruiting
Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS
Milan
Simone Gulletta, MD, gulletta.simone@hsr.it
Simone Gulletta, MD
- Recruiting
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan
Giovanni Battista Forleo, MD, PhD, 0239042789 ext. +39, forleo@me.com
Giovanni Forleo, MD, PhD
- Recruiting
Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS
Milan
Claudio Tondo, MD, PhD, claudio.tondo@cardiologicomonzino.it
Claudio Tondo, MD, PhD
- Recruiting
Department of Cardiology, ASST Monza, San Gerardo Hospital
Monza
Giovanni Rovaris, MD, rovaris.gi@gmail.com
Giovanni Rovaris, MD
- Recruiting
Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova
Padova
Federico Migliore, MD, 0498212311 ext. +39, federico.migliore@unipd.it
- Recruiting
Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)
Tricase
Pietro Palmisano, MD, dr.palmisano@libero.it
Pietro Palmisano, MD
Belgium1 site, 1 recruiting
- Recruiting
Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit
Brussels
Carlo De Asmundis, MD, Carlo.DeAsmundis@uzbrussel.be
Carlo De Asmundis, MD
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich,
Zurich
Ardan M Sagunder, MD, ardan.sagunder@usz.ch
Ardan M Sagunder, MD
About this study
Official title: International Ledless Pacemaker Registry (i-LEAPER)
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.
The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.
Read the detailed description
The study includes consecutive patients implanted with a pacemaker leadless device (Micra Transcatheter Pacing System; Medtronic, Inc., Minneapolis, MN, USA).
Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.
- Conditions
- Block Complete Heart, Atrial Fibrillation
- Being tested
- Leadless Pacemaker (Micra)
- Keywords
- leadless pacing
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless Pacemaker (Micra)Device
Micra leadless pacemaker is implanted in the right ventricle via femoral vein. The Micra introducer/dilator assembled system is inserted over a stiff guidewire in the right atrium. After the removal of the guidewire and the dilator, the delivery system is advanced into the introducer and the Micra is placed under fluoroscopy guidance, preferably in the septal region of the right ventricle.
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
overall mortality
Measured: through study completion, an average of 2 years
Implant complication rates
Dislodgments, Cardiac perforation, vascular complications (access site).
Measured: during and immediately after the intervention
Electrical performance of the pacing system
Pacing thresholds
Measured: Through study completion, an average of 2 years
Electrical performance of the pacing system
R wave sensing
Measured: Through study completion, an average of 2 years
Electrical performance of the pacing system
pacing impedances values
Measured: Through study completion, an average of 2 years
Upgrading with a different pacing system
Need of an additional transvenous pacing system
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Block Complete HeartStudies 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia, Centro Cardiologico Monzino, University Hospital, Zürich, Azienda Ospedaliera Cardinale G. Panico, Azienda Ospedaliera San Gerardo di Monza, IRCCS Azienda Ospedaliero-Universitaria di Bologna, San Raffaele University Hospital, Italy, Ospedale V. Fazzi, Ospedali Riuniti Ancona, Universitair Ziekenhuis Brussel, Università degli Studi di Ferrara, University of Padova
- Responsible party
- Principal investigator, Giovanni B Forleo, Luigi Sacco University Hospital
- Investigators
- Giovanni B Forleo, MD, PhD, Principal investigator, Luigi Sacco University HospitalGianfranco MItacchione, MD, PhD, Principal investigator, Luigi Sacco University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528029
- Sponsor's protocol ID
- Hsacco2022
- Acronym
- i-LEAPER
- Status last verified
- Dec 2022
- First submitted
- 31 Aug 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA, Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. doi: 10.1056/NEJMoa1511643. Epub 2015 Nov 9.
PubMed 26551877Mitacchione G, Schiavone M, Gasperetti A, Tripepi GL, Cerini M, Montemerlo E, Del Monte A, Bontempi L, Moltrasio M, Breitenstein A, Monaco C, Palmisano P, Rovaris G, Chierchia GB, Dello Russo A, Biffi M, de Asmundis C, Mazzone P, Di Biase L, Gallieni M, Tondo C, Curnis A, Forleo GB. Leadless pacemakers in patients with different stages of chronic kidney disease: Real-world data from the updated i-LEAPER registry. Heart Rhythm. 2025 Feb;22(2):325-331. doi: 10.1016/j.hrthm.2024.07.027. Epub 2024 Jul 17.
PubMed 39029882Mitacchione G, Schiavone M, Gasperetti A, Arabia G, Tundo F, Breitenstein A, Montemerlo E, Monaco C, Gulletta S, Palmisano P, Hofer D, Rovaris G, Dello Russo A, Biffi M, Pisano ECL, Della Bella P, Di Biase L, Chierchia GB, Saguner AM, Tondo C, Curnis A, Forleo GB. Sex differences in leadless pacemaker implantation: A propensity-matched analysis from the i-LEAPER registry. Heart Rhythm. 2023 Oct;20(10):1429-1435. doi: 10.1016/j.hrthm.2023.07.061. Epub 2023 Jul 20.
PubMed 37481220Mitacchione G, Schiavone M, Gasperetti A, Arabia G, Breitenstein A, Cerini M, Palmisano P, Montemerlo E, Ziacchi M, Gulletta S, Salghetti F, Russo G, Monaco C, Mazzone P, Hofer D, Tundo F, Rovaris G, Russo AD, Biffi M, Pisano ECL, Chierchia GB, Della Bella P, de Asmundis C, Saguner AM, Tondo C, Forleo GB, Curnis A. Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry. Heart Rhythm. 2023 Mar;20(3):395-404. doi: 10.1016/j.hrthm.2022.12.002. Epub 2022 Dec 7.
PubMed 36496135
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Ledless Pacemaker Registry (i-LEAPER)
- ClinicalTrials.gov ID
- NCT05528029
- Acronym / sponsor ID
- i-LEAPER / Hsacco2022
- Conditions
- Block Complete Heart, Atrial Fibrillation
- Keywords
- leadless pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia, Centro Cardiologico Monzino, University Hospital, Zürich, Azienda Ospedaliera Cardinale G. Panico, Azienda Ospedaliera San Gerardo di Monza, IRCCS Azienda Ospedaliero-Universitaria di Bologna, San Raffaele University Hospital, Italy, Ospedale V. Fazzi, Ospedali Riuniti Ancona, Universitair Ziekenhuis Brussel, Università degli Studi di Ferrara, University of Padova
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Sep 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.
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.
The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.
Detailed description
The study includes consecutive patients implanted with a pacemaker leadless device (Micra Transcatheter Pacing System; Medtronic, Inc., Minneapolis, MN, USA).
Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Leadless Pacemaker (Micra)Micra leadless pacemaker is implanted in the right ventricle via femoral vein. The Micra introducer/dilator assembled system is inserted over a stiff guidewire in the right atrium. After the removal of the guidewire and the dilator, the delivery system is advanced into the introducer and the Micra is placed under fluoroscopy guidance, preferably in the septal region of the right ventricle. | Device | – |
Primary outcome
All cause mortality
Time frame: through study completion, an average of 2 years
overall mortality
Implant complication rates
Time frame: during and immediately after the intervention
Dislodgments, Cardiac perforation, vascular complications (access site).
Electrical performance of the pacing system
Time frame: Through study completion, an average of 2 years
Pacing thresholds
Electrical performance of the pacing system
Time frame: Through study completion, an average of 2 years
R wave sensing
Electrical performance of the pacing system
Time frame: Through study completion, an average of 2 years
pacing impedances values
Upgrading with a different pacing system
Time frame: Through study completion, an average of 2 years
Need of an additional transvenous pacing system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Results publication: PubMed 26551877Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA, Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. doi: 10.1056/NEJMoa1511643. Epub 2015 Nov 9.
- Derived from this study: PubMed 39029882Mitacchione G, Schiavone M, Gasperetti A, Tripepi GL, Cerini M, Montemerlo E, Del Monte A, Bontempi L, Moltrasio M, Breitenstein A, Monaco C, Palmisano P, Rovaris G, Chierchia GB, Dello Russo A, Biffi M, de Asmundis C, Mazzone P, Di Biase L, Gallieni M, Tondo C, Curnis A, Forleo GB. Leadless pacemakers in patients with different stages of chronic kidney disease: Real-world data from the updated i-LEAPER registry. Heart Rhythm. 2025 Feb;22(2):325-331. doi: 10.1016/j.hrthm.2024.07.027. Epub 2024 Jul 17.
- Derived from this study: PubMed 37481220Mitacchione G, Schiavone M, Gasperetti A, Arabia G, Tundo F, Breitenstein A, Montemerlo E, Monaco C, Gulletta S, Palmisano P, Hofer D, Rovaris G, Dello Russo A, Biffi M, Pisano ECL, Della Bella P, Di Biase L, Chierchia GB, Saguner AM, Tondo C, Curnis A, Forleo GB. Sex differences in leadless pacemaker implantation: A propensity-matched analysis from the i-LEAPER registry. Heart Rhythm. 2023 Oct;20(10):1429-1435. doi: 10.1016/j.hrthm.2023.07.061. Epub 2023 Jul 20.
- Derived from this study: PubMed 36496135Mitacchione G, Schiavone M, Gasperetti A, Arabia G, Breitenstein A, Cerini M, Palmisano P, Montemerlo E, Ziacchi M, Gulletta S, Salghetti F, Russo G, Monaco C, Mazzone P, Hofer D, Tundo F, Rovaris G, Russo AD, Biffi M, Pisano ECL, Chierchia GB, Della Bella P, de Asmundis C, Saguner AM, Tondo C, Forleo GB, Curnis A. Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry. Heart Rhythm. 2023 Mar;20(3):395-404. doi: 10.1016/j.hrthm.2022.12.002. Epub 2022 Dec 7.
- 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. This study is not recruiting at the moment.
Giovanni B Forleo, MD, PhD principal investigator
Luigi Sacco University Hospital
Gianfranco MItacchione, MD, PhD principal investigator
Luigi Sacco University Hospital
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Block Complete Heart and Atrial Fibrillation, run by Luigi Sacco University Hospital at 12 sites in 3 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 0 inclusion and 1 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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Belgium, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni B Forleo, MD, PhD (390239042789, forleo@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: through study completion, an average of 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528029, which also lists 4 linked publications.
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 23 Dec 2022.