Bradycardia SinusNCT06910059
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
An observational study of Bradycardia Sinus and AV Block, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in China.
Trial summary
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location. The secondary objective is (1) to identify an optimal Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- What is being tested?
- Observational
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2025to 31 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll up to 40 subjects in site. Patients with pacing indications who plan to receive Micra AV implantation will be selected.
Who may be able to join
- Patients aged above 18 years old
- Patients who are willing to provide Informed Consent
- Patients with Class I or II indications who plan to receive a leadless pacemaker, including SSS, AVB, AF with bradycardia, etc.
- Patients who plan to conduct a cardiac CT scan after implantation
Who cannot join
- Patients with lead retention
- Patients had heart valve replacement
- Patients diagnosed with ischemic heart diseases
- Patients who are allergic to or refuse to use contrast in CT scans
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients with medical conditions that would limit study participation
- Patients already enrolled in another clinical trial which would impact participation of this study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
About this study
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
The secondary objective is (1) to identify an optimal Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and tricuspid regurgitation, and (3) to investigate whether Micra location would impact AV synchrony. Patients with pacing indications who plan to receive Micra AV implantation will be recruited.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Being tested
- Observational
- Medical subject headings
- Atrioventricular Block, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
It is a observational study and patients with pacing indications who plan to receive Micra AV implantation will be recruited. No intervention procedure will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ECG characteristics in relation to Micra tip location
Patients' ECG will be measured to see whether there is difference in ECG characteristics between Micra tip locations.
Measured: Within 6 months after the surgery.
Secondary outcomes (2)
Cardiac functional changes
LVEF, RV length and quantity of tricuspid regurgitation will be measured.
Measured: Within 6 months after the surgery.
To investigate whether Micra location would impact AV synchrony
Percentage of AV synchrony will be measured.
Measured: Within 6 months after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start17 Jun 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bradycardia SinusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910059
- Sponsor's protocol ID
- Micra-CT EM Study
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26551877Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, Moons KG. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012 May;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. Epub 2011 Dec 17.
PubMed 22182495Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17.
PubMed 24347317
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
- ClinicalTrials.gov ID
- NCT06910059
- Acronym / sponsor ID
- Micra-CT EM Study
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 4 Apr 2025 (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 goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
The secondary objective is (1) to identify an optimal Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and tricuspid regurgitation, and (3) to investigate whether Micra location would impact AV synchrony. Patients with pacing indications who plan to receive Micra AV implantation will be recruited.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll up to 40 subjects in site. Patients with pacing indications who plan to receive Micra AV implantation will be selected.
Key inclusion criteria (4 listed)
- Patients aged above 18 years old
- Patients who are willing to provide Informed Consent
- Patients with Class I or II indications who plan to receive a leadless pacemaker, including SSS, AVB, AF with bradycardia, etc.
- Patients who plan to conduct a cardiac CT scan after implantation
Key exclusion criteria (7 listed)
- Patients with lead retention
- Patients had heart valve replacement
- Patients diagnosed with ischemic heart diseases
- Patients who are allergic to or refuse to use contrast in CT scans
- Patients who are pregnant or have a plan for pregnancy during the study
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 |
|---|---|---|
| ObservationalIt is a observational study and patients with pacing indications who plan to receive Micra AV implantation will be recruited. No intervention procedure will be performed. | Other | – |
Primary outcome
Assessment of ECG characteristics in relation to Micra tip location
Time frame: Within 6 months after the surgery.
Patients' ECG will be measured to see whether there is difference in ECG characteristics between Micra tip locations.
2 secondary outcomes
Cardiac functional changes
Time frame: Within 6 months after the surgery.
To investigate whether Micra location would impact AV synchrony
Time frame: Within 6 months after the surgery.
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 1 May 2026.
- 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.
- Results publication: PubMed 22182495Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, Moons KG. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012 May;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. Epub 2011 Dec 17.
- Results publication: PubMed 24347317Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bradycardia Sinus and AV Block, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in China.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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 China. 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?
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?
Assessment of ECG characteristics in relation to Micra tip location (time frame: Within 6 months after the surgery.). 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 NCT06910059, which also lists 3 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 1 May 2026.