Sinus PauseMAPNCT07908927
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
A study testing Cardiac Imaging by TTE or CTA in people with Sinus Pause and Sinus Sick Syndrome, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and computed tomography angiography (CTA) of the heart will help guide future implant… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sinus Pause, Sinus Sick Syndrome, Heart Block
- What is being tested?
- Cardiac Imaging by TTE or CTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 31 May 2028
- Phase
- Interventional
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18-89, inclusive.
- All patients undergoing implant of a new Micra VR or AV2 leadless pacemaker.
Who cannot join
- Women who are pregnant or breastfeeding
- Existing device implant
- Breast or Pectoral Implants
- Patients with a GFR less than 45, unless the patient is on dialysis (in which case, may be included)
- Known allergy to iodinated contrast.
- Any other condition or finding that, in the opinion of the investigator, would contraindicate participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Heather McDonald, MHA, 412-359-3660, heather.mcdonald@ahn.org
Joshua Silverstein, MD
About this study
Official title: Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning (MAP)
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and computed tomography angiography (CTA) of the heart will help guide future implant techniques. We hypothesize that TTE-guided implantation would lead to improved safety and accuracy of leadless pacemaker implants.
The implanter and two independent electrophysiologists will estimate the location of the implant based on standard fluoroscopic views using RV site nomenclature after the procedure. Each participant will then undergo a TTE and have 3 independent assessments of the implant site. Within 48 hours of the implant, a CTA of the heart will then be performed with contrast, which will serve as the gold standard to determine the actual implant site.
The primary endpoint will compare implanting electrophysiologist, fluoroscopy, and TTE predicted location of a new implanted Micra VR or AV2 leadless pacemaker to the implant location found on a gold standard CTA of the heart. The secondary endpoints will compare implant technique (Jugular vs. Femoral) by defining timing of implant procedure, repositioning, and accuracy of predicted implant location. The other secondary endpoints will compare baseline and demographic characteristics (BMI, COPD, LVEF, implant technique) to EKG parameters at final position, fluoroscopy and TTE image quality, acquisition of triangle or Koch and Bachmann area view during TTE.
- Conditions
- Sinus Pause, Sinus Sick Syndrome, Heart Block, Arrhythmias, Cardiac
- Being tested
- Cardiac Imaging by TTE or CTA
- Medical subject headings
- Atrial Standstill, Sick Sinus Syndrome, Heart Block, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Imaging by TTE or CTADiagnostic test
After a standard care pacemaker implantation, participants will undergo two standard care imaging procedures which will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | All patients undergoing a new Micra VR or AV2 leadless pacemaker implant will be considered for recruitment. After the consent and screening processes, eligible participants will undergo their standard-care implantation procedure according to clinical guidelines. After the implantation procedure is complete, the study investigation will start when the participant undergoes a TTE and CTA imaging of the heart. Receives: Diagnostic Test: Cardiac Imaging by TTE or CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess accuracy predicted implant locations to CTA
Compare implanting electrophysiologist-, fluoroscopy-, and TTE-predicted location of a new implanted Micra VR or AV2 leadless pacemaker to the implant location found on a gold standard modality, CTA of the heart. [measure: location accuracy]
Measured: 3 months
Secondary outcomes (4)
Implant technique timing
Compare time required for Jugular vs. Femoral implant techniques [measure: minutes}
Measured: 1 hour
Implant technique repositioning
Compare Jugular vs. Femoral implant techniques by defining repositioning attempts [measure: number of attempts]
Measured: 1 hour
Implant technique prediction accuracy
Compare Jugular vs. Femoral implant techniques by defining the accuracy of predicted implant location [measure: percentage]
Measured: 1 hour
Baseline characteristics
Compare baseline characteristics (BMI, COPD, LVEF, implant technique) to EKG parameters at final position, fluoroscopy and TTE image quality, acquisition of triangle or Koch and Bachmann area view during TTE [measure: scale 1-5]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start13 May 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus PauseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single center, prospective, pilot study comparing fluoroscopy (standard of care) and echocardiography to gold standard CTA to evaluate Micra device implant location.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908927
- Sponsor's protocol ID
- MAP
- Acronym
- MAP
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning (MAP)
- ClinicalTrials.gov ID
- NCT07908927
- Acronym / sponsor ID
- MAP / MAP
- Conditions
- Sinus Pause, Sinus Sick Syndrome, Heart Block, Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and computed tomography angiography (CTA) of the heart will help guide future implant techniques. We hypothesize that TTE-guided implantation would lead to improved safety and accuracy of leadless pacemaker implants.
The implanter and two independent electrophysiologists will estimate the location of the implant based on standard fluoroscopic views using RV site nomenclature after the procedure. Each participant will then undergo a TTE and have 3 independent assessments of the implant site. Within 48 hours of the implant, a CTA of the heart will then be performed with contrast, which will serve as the gold standard to determine the actual implant site.
The primary endpoint will compare implanting electrophysiologist, fluoroscopy, and TTE predicted location of a new implanted Micra VR or AV2 leadless pacemaker to the implant location found on a gold standard CTA of the heart. The secondary endpoints will compare implant technique (Jugular vs. Femoral) by defining timing of implant procedure, repositioning, and accuracy of predicted implant location. The other secondary endpoints will compare baseline and demographic characteristics (BMI, COPD, LVEF, implant technique) to EKG parameters at final position, fluoroscopy and TTE image quality, acquisition of triangle or Koch and Bachmann area view during TTE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center, prospective, pilot study comparing fluoroscopy (standard of care) and echocardiography to gold standard CTA to evaluate Micra device implant location.
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Diagnostic Test: Cardiac Imaging by TTE or CTAAll patients undergoing a new Micra VR or AV2 leadless pacemaker implant will be considered for recruitment. After the consent and screening processes, eligible participants will undergo their standard-care implantation procedure according to clinical guidelines. After the implantation procedure is complete, the study investigation will start when the participant undergoes a TTE and CTA imaging of the heart. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients aged 18-89, inclusive.
- All patients undergoing implant of a new Micra VR or AV2 leadless pacemaker.
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding
- Existing device implant
- Breast or Pectoral Implants
- Patients with a GFR less than 45, unless the patient is on dialysis (in which case, may be included)
- Known allergy to iodinated contrast.
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 |
|---|---|---|
| Cardiac Imaging by TTE or CTAAfter a standard care pacemaker implantation, participants will undergo two standard care imaging procedures which will be compared. | Diagnostic test | Investigational |
Primary outcome
Assess accuracy predicted implant locations to CTA
Time frame: 3 months
Compare implanting electrophysiologist-, fluoroscopy-, and TTE-predicted location of a new implanted Micra VR or AV2 leadless pacemaker to the implant location found on a gold standard modality, CTA of the heart. [measure: location accuracy]
4 secondary outcomes
Implant technique timing
Time frame: 1 hour
Implant technique repositioning
Time frame: 1 hour
Implant technique prediction accuracy
Time frame: 1 hour
Baseline characteristics
Time frame: 3 months
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 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Sinus Pause
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Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
Vasovagal Syncope, AV Block-2Nd Degree-Type 1
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Imaging by TTE or CTA in people with Sinus Pause and Sinus Sick Syndrome, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
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 2 inclusion and 6 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 2 Nov 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 United States. 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 Caitlin Phalunas, MSBME (412-359-3747, caitlin.phalunas@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess accuracy predicted implant locations to CTA (time frame: 3 months). 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 2 Nov 2026.