| CTRI Number |
CTRI/2025/05/086854 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Conduction System Pacing Display System in Measuring device parameters during the Pacemaker implant procedure. |
|
Scientific Title of Study
|
Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer (CSP Display)
|
| Trial Acronym |
CSP Display Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park, Bldg. No. 12, 6th Floor,
Andheri - Ghatkopar Link Road,
Andheri (East), Mumbai - 400093, India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park, Bldg. No. 12, 6th Floor,
Andheri - Ghatkopar Link Road,
Andheri (East), Mumbai - 400093, India
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park, Bldg. No. 12, 6th Floor,
Andheri - Ghatkopar Link Road,
Andheri (East), Mumbai - 400093, India
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| Medtronic, Inc. 8200 Coral Sea Street NE, Mounds View, MN U.S.A. 55112 |
|
|
Primary Sponsor
|
| Name |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park, Bldg. No. 12, 6th Floor,
Andheri - Ghatkopar Link Road,
Andheri (East), Mumbai - 400093, India
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Narasimhan |
AIG Hospital |
Asian Institute of Gastroenterology, Survey No 136, Plot No 2/3/4/5, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana, 500032
Hyderabad
TELANGANA |
9848052409
calambur1@gmail.com |
| Dr Narayanan Namboodiri |
Sree Chitra Institute for Medical Science and Technology |
Jai Nagar W Rd, Chalakkuzhi,Thiruvananthapuram, Kerala, India 695011
Thiruvananthapuram
KERALA |
9447223340
kknnamboodiri@gmail.com |
| Dr P Shunmuga Sundaram |
Velammal Medical College Hospital and Research Institute |
Madurai-Tuticorin Ring Road, Velammal, Anuppanadi Near Chinthamani, Madurai, Tamil Nadu, 625009
Madurai
TAMIL NADU |
8825663660
shunmuga.pgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee SCTIMST |
Submittted/Under Review |
| Institutional Ethics Committee Velammal Medical College Hospital & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CSP Display research System |
The Conduction System Pacing (CSP) Display Research System is a modified SmartSync Pacing System Analyzer (PSA) with the CSP Display Investigational Software, and market approved leads and other components, to provide visualization of multi-channel ECGs.
The CSP Display Research System will be single time data collection for each patient during the standard of care procedure of pacemaker implant. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject is at least 18 years of age
2. Subject is willing and able to provide written informed consent
3.Subject is willing and able to comply with the protocol
4. Subject meets eligibility for de-novo pacemaker implant (single or dual chamber) with left bundle
branch area pacing (LBBAP) therapy using the Model 3830 lead |
|
| ExclusionCriteria |
| Details |
1. Subject is not available to comply with visit schedule
2. 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)
3. 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.
4. Subject meets any exclusion criteria required by local law
5. Vulnerable adults (i.e. subjects incapable of giving consent) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the automatic LVAT measurement from surface ECG of the CSP Display research system to manual LVAT measurement of ECG from a commercial EP recording system during the procedure of pacemaker implant with LBBAP |
Pacemaker implant procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Compare surface ECG V1 morphology between the CSP Display research system & a commercial EP recording system during a pacemaker implant with LBBAP. |
Pacemaker implant procedure |
| Collect ECG, EGM, Marker channel, & LVAT data from the SmartSync PSA system, & 12-lead ECG & EGM from a commercial system for future CSP algorithm development |
Pacemaker implant procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer (CSP Display) study is to use the Conduction System Pacing (CSP) Display Research System to provide visualization of multi-channel ECGs including precordial ECG leads (V1, V6 or V5), and provide automatic measurement of LVAT based on surface ECG V6 or V5, during the pacemaker implant procedure. These are commonly used parameters to confirm a successful implant and LBBP lead positioning. This pre-market feasibility study has the aim to assess if the novel CSP Display Research System can perform well for its intended use and can perform effectively compared to the EP recording system. With the growing adoption of CSP especially with LBBAP, the CSP Display Research System can provide an improved tool to aid implant and perform continuous monitoring, exploring the possibility of potentially using a programmer as the only device during LBB lead implant and follow-up, to simplify those procedures.
|