BradycardiaCSP DisplayNCT07733960
Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
An observational study of Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in India.
Trial summary
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- CSP Display research system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesIndia
- Study dates
- 21 May 2026to 30 Jul 2027
- 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: The target population for the CSP Display study will include subjects who are indicated to receive a de-novo pacemaker implant (single or dual chamber) with left bundle branch area pacing (LBBAP) based on market approved indications.
Who may be able to join
- Subject is at least 18 years of age
- Subject is willing and able to provide written informed consent
- Subject is willing and able to comply with the protocol
- Subject meets eligibility for de-novo implant of a pacemaker (single or dual chamber) with left bundle branch area pacing (LBBAP) therapy
Who cannot join
- Subject is not available to comply with visit schedule
- Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
- Subject is currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
- Subject meets any exclusion criteria required by local law
- Vulnerable adults (i.e. subjects incapable of giving consent)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sr Director - Clinical Research and Medical Science, Medtronic contact
India2 sites, 2 recruiting
- Recruiting
Asian Institute of Gastroenterology(AIG) hospitals
Hyderabad, Telegana
Walli Mohammed, drwallimohammedaig@yahoo.com
Calambur Narasimhan, MD
- Recruiting
Velammal Medical College Hospital and Research Institute
Madurai, Tamil Nadu
Saravanakumar Govindasamy, vmc.cardiacresearch@gmail.com
Shunmuga Sundaram
About this study
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording device during the pacemaker implantation. Participants receiving a routine de-novo implantation of a pacemaker for left bundle branch area pacing (LBBAP) will undergo the CSP Display System protocol during the implant procedure.
Read the detailed description
This feasibility study evaluates the use of the CSP Display Research System during single- or dual-chamber pacemaker implantation for left bundle branch area pacing (LBBAP). The system provides visualization of electrocardiogram data and automatic measurement of left ventricular activation time. Measurements using the CSP Display Research System will be compared with measurements obtained from a standard electrophysiology (EP) recording system used during the implant procedure as part of standard clinical practice. This study also includes exploratory collection of electrocardiogram, intracardiac electrogram, pacemaker marker channel, and left ventricular activation time data during the implant procedure to support future research and algorithm development. These data will be collected for exploratory purposes and do not have a pre-specified evaluation in this study.
- Conditions
- Bradycardia
- Being tested
- CSP Display research system
- Keywords
- Left bundle branch area pacing (LBBAP)
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSP Display research systemDevice
Research system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving a clinically indicated single- or dual-chamber pacemaker implantation | Patients with left bundle branch area pacing will have measurements collected using the CSP Display Research System for visualisation of surface electrocardiogram data and automatic measurement of left ventricular activation time for comparison with a standard electrophysiology recording system. Receives: Device: CSP Display research system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Activation Time (LVAT)
LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system
Measured: During pacemaker implant procedure
Secondary outcomes (1)
Surface ECG V1 morphology
V1 morphology observed using the CSP Display Research System and a commercial electrophysiology recording system.
Measured: During pacemaker implant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start21 May 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- 100 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
- NCT07733960
- Sponsor's protocol ID
- CSP Display Study
- Acronym
- CSP Display
- Status last verified
- Jul 2026
- First submitted
- 18 May 2026
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
- ClinicalTrials.gov ID
- NCT07733960
- Acronym / sponsor ID
- CSP Display / CSP Display Study
- Conditions
- Bradycardia
- Keywords
- Left bundle branch area pacing (LBBAP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 29 Jul 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.
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording device during the pacemaker implantation. Participants receiving a routine de-novo implantation of a pacemaker for left bundle branch area pacing (LBBAP) will undergo the CSP Display System protocol during the implant procedure.
Detailed description
This feasibility study evaluates the use of the CSP Display Research System during single- or dual-chamber pacemaker implantation for left bundle branch area pacing (LBBAP). The system provides visualization of electrocardiogram data and automatic measurement of left ventricular activation time. Measurements using the CSP Display Research System will be compared with measurements obtained from a standard electrophysiology (EP) recording system used during the implant procedure as part of standard clinical practice. This study also includes exploratory collection of electrocardiogram, intracardiac electrogram, pacemaker marker channel, and left ventricular activation time data during the implant procedure to support future research and algorithm development. These data will be collected for exploratory purposes and do not have a pre-specified evaluation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving a clinically indicated single- or dual-chamber pacemaker implantation | – | Device: CSP Display research systemPatients with left bundle branch area pacing will have measurements collected using the CSP Display Research System for visualisation of surface electrocardiogram data and automatic measurement of left ventricular activation time for comparison with a standard electrophysiology recording system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for the CSP Display study will include subjects who are indicated to receive a de-novo pacemaker implant (single or dual chamber) with left bundle branch area pacing (LBBAP) based on market approved indications.
Key inclusion criteria (4 listed)
- Subject is at least 18 years of age
- Subject is willing and able to provide written informed consent
- Subject is willing and able to comply with the protocol
- Subject meets eligibility for de-novo implant of a pacemaker (single or dual chamber) with left bundle branch area pacing (LBBAP) therapy
Key exclusion criteria (5 listed)
- Subject is not available to comply with visit schedule
- Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
- Subject is currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
- Subject meets any exclusion criteria required by local law
- Vulnerable adults (i.e. subjects incapable of giving consent)
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 |
|---|---|---|
| CSP Display research systemResearch system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time | Device | Patients receiving a clinically indicated single- or dual-chamber pacemaker implantation |
Primary outcome
Left Ventricular Activation Time (LVAT)
Time frame: During pacemaker implant procedure
LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system
1 secondary outcome
Surface ECG V1 morphology
Time frame: During pacemaker implant procedure
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 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Bradycardia
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BIO|MASTER.CSP Study
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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.
Sr Director - Clinical Research and Medical Science, Medtronic contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in India.
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 5 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 Sr Director - Clinical Research and Medical Science, Medtronic (+91-2233074700, vinay.rajan@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Activation Time (LVAT) (time frame: During pacemaker implant procedure). 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 29 Jul 2026.