| CTRI Number |
CTRI/2025/07/090144 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety and effectiveness of the CSP ICD Lead in participants implanted with ICD or CRT-D therapy |
|
Scientific Title of Study
|
A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ABT-CIP-10549 Ver. B dated 21Feb2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Anand |
| Designation |
Associate Director |
| Affiliation |
Abbott India Pvt.Ltd. |
| Address |
Ground Floor, Dept. of Clinical Research, Room No-2,
Plot no 100, Okhla Industrial Estate
New Delhi
DELHI
110020
India |
| Phone |
|
| Fax |
|
| Email |
sumit.anand@abbott.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Anand |
| Designation |
Associate Director |
| Affiliation |
Abbott India Pvt.Ltd. |
| Address |
Ground Floor, Dept. of Clinical Research, Plot no 100
Okhla Industrial Estate, Phase-III
New Delhi
DELHI
110020
India |
| Phone |
01142600100 |
| Fax |
|
| Email |
sumit.anand@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Anand |
| Designation |
Associate Director |
| Affiliation |
Abbott India Pvt.Ltd. |
| Address |
Ground Floor, Dept. of Clinical Research, Plot no 100
Okhla Industrial Estate, Phase-III
DELHI
110020
India |
| Phone |
01142600100 |
| Fax |
|
| Email |
sumit.anand@abbott.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abbott India Pvt. Ltd. |
| Address |
Dpt. of Clinical Research, Ground Floor, Plot no. 100, Okhla Industrial
Estate, Phase-III, D New Delhi 110020 |
| Type of Sponsor |
Other [Medical Devices] |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| St Jude Medical Idia Pvt Ltd |
1-11-250/A, Matarani Sensation Building, Lane Besides Syndicate Bank, Begumpet, Hyderabad (india)- 500016 |
|
|
Countries of Recruitment
|
Australia
Canada
Hong Kong
India
Singapore
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balbir Singh |
Max Super Specialty Hospital |
East block -A unit of Devki Devi Foundation
2, Press Enclave Road, Saket, 110017, India
New Delhi
DELHI |
9810842890
drbalbirs@gmail.com |
| Dr K K Narayanan Namboodiri |
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) |
Room No. 45, Ist Floor, Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, SCTIMST, Trivandrum -695011, Kerala
Thiruvananthapuram
KERALA |
919447223340
kknnambodiri@sctimst.ac.in |
| Dr Shunmuga Sundaram |
Velammal Medical College Hospital |
"Velammal Village", Anuppanadi, 625009
Madurai
TAMIL NADU |
919444712846
shunmuga.pgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| Institutional Ethics Committee SCTIMST |
Approved |
| Institutional Ethics Committee, Max Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I420||Dilated cardiomyopathy, (2) ICD-10 Condition: I501||Left ventricular failure, unspecified, (3) ICD-10 Condition: I428||Other cardiomyopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ICD or CRT-D |
The left bundle branch area pacing with ICD or CRT-D implants as per standard procedure |
| Comparator Agent |
No comparator |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
a. de novo Abbott ICD system implant (single or dual chamber)
b. de novo Abbott CRT-D system implant and is intended to also undergo left ventricle coronary sinus lead implant (for patients indicated for CRT-D according to locally approved indications)
2. Subject is more than 18 years of age or age of legal consent, whichever age is greater.
3. Subject is willing to undergo implant defibrillation testing if requested. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure.
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC. |
|
| ExclusionCriteria |
| Details |
General Exclusion Criteria
1. Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
2. Subject has had recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
3. Subject has had any other therapeutic cardiovascular procedure (such as transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent or planned within 3 months following consent
4. Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
5. Subject has a life expectancy of less than 12 months
6. Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
7. Subject is contraindicated for less than or equal to 1mg Dexamethasone sodium phosphate.
8. Subject is pregnant or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
9. Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads
10. Subject has any evidence of active infection or undergoing treatment for an infection
11. Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
12. Subject has moderate or severe aortic stenosis
13. Subject has ventricular septal defect (VSD) or had prior surgery on the interventricular septum that could impact LBBAP implant, such as septal myomectomy, ethanol septal ablation, VSD repair, etc
14. Subject has end stage renal disease
15. Subject has NYHA IV classification
16. Subject has undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
17. Subject has had previously extracted leads
18. Subject has had an LV Assist Device
19. Subject has had a failed LBBAP lead implant
Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):
1. Subject has pre existing or suspected pneumothorax during implant
2. Subject has current known intracardiac left atrial or Left Ventricular thrombus
3. Subject has severe proximal three vessel or left main coronary artery disease without revascularization
4. Subject has Ejection Fraction less than 20%
5. Subject has recent stroke or transient ischemic attack (within the last 6 months)
6. Subject has known inadequate external defibrillation
7. Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - The primary safety endpoint evaluates the freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted, based on Clinical Event Committee (CEC) adjudication of adverse events. |
3 months post-implant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the 3-month composite success rate of acceptable pacing capture thresholds & R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA. Acceptable ranges for pacing capture threshold & sense amplitude are shown below:
- Pacing threshold less than or equal to 2.5V at pulse width of 0.5ms
- Sense amplitude: more than or equal to 3.0 mV |
3 months |
| To evaluate the success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA. |
Implant |
|
|
Target Sample Size
|
Total Sample Size="414"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
21/07/2025 |
| Date of Study Completion (India) |
03/12/2025 |
| Date of First Enrollment (Global) |
11/04/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This clinical study will evaluate the safety and effectiveness of the CSP ICD Lead when implanted at the LBBA location in a subject population indicated for ICD or CRT-D therapy. It is a Prospective, global, single-arm, multi-center IDE study. The study will enroll up to 414 subjects at up to 70 sites worldwide (US, Canada, EMEA, and APAC) to analyze the primary endpoints. The subjects will be followed at baseline, implant procedure, pre (hospital) discharge, and follow-up at 3 months (primary endpoints evaluation), 6 months, and every 6 months thereafter until study completion. |