| CTRI Number |
CTRI/2024/10/075223 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ACURATE neo2 and SENTINEL Post-Market Study |
|
Scientific Title of Study
|
A Post-Market Study of the Use of ACURATE neo2TM Transfemoral Valve System with or without SENTINELâ„¢ Cerebral Protection System in Treating Patients with Symptomatic Severe Aortic Stenosis. ACURATE neo2 and SENTINEL Post Market study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 92935749 Verion D 28 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Seth |
| Designation |
Chairman |
| Affiliation |
Fortis Escorts Heart Institute |
| Address |
Fortis Escorts Heart Institute
Okhla Road, Sukhdev Vihar Metro Station, New Delhi,110025, Delhi India
New Delhi
DELHI
110025
India |
| Phone |
11105010 |
| Fax |
|
| Email |
Ashok.seth@fortishealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant Janbandhu |
| Designation |
Clinical Trial Lead |
| Affiliation |
Boston Scientific India |
| Address |
Boston Scientific India Bestech Business Tower
3rd Floor, Sohna Road, Sector-48
Gurugram - 122 018
Haryana, India
Gurgaon
HARYANA
122 018
India |
| Phone |
09324293280 |
| Fax |
|
| Email |
prashant.janbandhu@bsci.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant Janbandhu |
| Designation |
Clinical Trial Lead |
| Affiliation |
Boston Scientific India |
| Address |
Boston Scientific India Bestech Business Tower
3rd Floor, Sohna Road, Sector-48
Gurugram - 122 018
Haryana, India
Gurgaon
HARYANA
122 018
India |
| Phone |
09324293280 |
| Fax |
|
| Email |
prashant.janbandhu@bsci.com |
|
|
Source of Monetary or Material Support
|
| Boston Scientific India, Bestech Business Tower,
3rd Floor, Sohna Road, Sector-48,
Gurugram - 122 018,
Haryana, India
|
|
|
Primary Sponsor
|
| Name |
Boston Scientific India |
| Address |
Boston Scientific India, Bestech Business Tower,
3rd Floor, Sohna Road, Sector-48,
Gurugram - 122 018,
Haryana, India
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gunsekaran Sengottuvelu |
Apollo hospital Chennai |
Apollo Hospitals Cardilogy Department Greams Road. 21, Greams Lane, Off Greams Road Chennai – 600006, India
Chennai
TAMIL NADU |
9841430999
drgseng@gmail.com |
| Dr Ranjit Nath |
Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital |
Cardiac Unit(CCU)
Ward No1 New Building
Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi -11000
New Delhi
DELHI |
9971138171
ranjitknath@yahoo.com |
| Dr John Jose |
CHRISTIAN MEDICAL COLLEGE VELLORE |
Christian Medical College Hospital Cardiology department 6 floor Ranipet Campus Vellore
Vellore
TAMIL NADU |
9843593721
drjohnjose@gmail.com |
| Dr Ashok Seth |
Fortis Escorts Heart Institute |
Okhla road, Sukhdev Vihar Metro Station, New Delhi, Delhi 110025, India
New Delhi
DELHI |
011-47135000
ashok.seth@fortishealthcare.com |
| Dr Ajaykumar Mahajan |
KSeth GS Medical College & K.E.M Hospital, Department of Cardiology |
Seth GS Medical College & K.E.M Hospital,
Department of Cardiology
Acharya Donde Marg, Parel, Mumbai 400 012. India.
Mumbai
MAHARASHTRA |
9920432639
draumahajan@gmail.com |
| Dr Praveen Chandra |
Medanta-The Medicity Hospital |
3rd Floor Cardiology department Sector 38, Gurgaon, Haryana 122001
Gurgaon
HARYANA |
9810125370
praveen63@hotmail.com |
| Dr Bhyravavajhala Srinivas |
Nizams Institute of Medical Sciences |
Department of Cardiology,
speciality Block,2nd Floor
Punjagutta road Punjagutta market Punjagutta Hyderabad Telangana 500082
Hyderabad
TELANGANA |
9866228933
srinivasb1210@gmail.com |
| Dr Ravinder Singh Rao |
Rajasthan Hospital Limited |
Cardiology department RHL Hospital Rd, opp. Jaipuria Hospital, Kailash Puri Colony, Milap Nagar, Jaipur, Rajasthan 302018
Jaipur
RAJASTHAN |
9116000383
rsrao.sn@gmail.com |
| Dr Sandeep Bansal |
Safdarjung Hospital Delhi |
Department of Cariology Room no 754 7th Floor Superspeciality Buidling Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
New Delhi
DELHI |
9810543368
drsbansal2000@yahoo.com |
| Dr CN Manjunath |
Shri.Jayadeva Institute of Cardiology |
Sri Jayadeva Institute of Cardiovascular Sciences & Research, Cardiology Department
Bangalore
KARNATAKA |
9844006699
draumahajan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| IEC Seth GS Medical College and KEM Hospital |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE - Fortis Heart Institute Delhi |
Approved |
| Institutional Ethics Committee ABVIMS |
Submittted/Under Review |
| Institutional ethics committee CMC Research office, Carman block, Bagayam, Vellore- 632002 |
Submittted/Under Review |
| Institutional Ethics Committee VMMC and SJH |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE-CLINICAL STUDIES (IEC-CS) APOLLO HOSPITALS, CHENNAI. |
Submittted/Under Review |
| Medanta Institute of Education and Research Regulatory |
Submittted/Under Review |
| NIMS-Institutional Ethics Committee Nizams Institute of Medical Sciences, |
Submittted/Under Review |
| RHL Ethics Committee |
Submittted/Under Review |
| Sri Jayadeva Ethics Committee, |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Transcatheter Aortic Valve
Implant |
TAVR procedure with ACURATE neo2â„¢ Transfemoral Valve System, with or without the use of SENTINELâ„¢ Cerebral Protection System. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject should be greater than 65 years of age.
2.Subject (or legal guardian) understands the study requirements and procedure, and provides written informed consent, and is willing to comply with all protocol-required follow-up evaluations.
3.Subject is clinically indicated for TAVR to treat symptomatic severe aortic stenosis with the ACURATE neo2TM Transfemoral Aortic Valve System according to the approved indication.
4.For subjects intended to use the SENTINELTM Cerebral Protection System in TAVR procedure, the diameters of subject’s left common carotid artery and brachiocephalic artery must be compatible with the SENTINELTM System.
|
|
| ExclusionCriteria |
| Details |
1.Subject has any of the contraindications listed in the IFU of study devices.
2.Subject had carotid stenting or carotid endarterectomy within the past 2 months.
3.Subject is currently enrolled in another investigational drug or device clinical trial that would directly interfere with this study.
4.Subject has known hypersensitivity or contraindications to contrast agent that, in the opinion of the investigator, cannot be adequately pre-medicated.
5.Subject has known hypersensitivity/allergy to the study device or protocol related therapies.
6.Subject has any medical condition that, in the opinion of the investigator, is not suitable to use the study devices.
7.Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on assessment of the investigator at the time of enrollment.
8.Subject is unable or not willing to complete follow-up visits and examinations including telephonic follow-ups for the duration of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
All cause mortality through 30 days post index procedure
Occurrence of major adverse events MAE, defined as a composite of all cause death, all stroke, transient ischemic attack TIA, major vascular complications, major and life-threatening bleeding events and acute kidney injury (stage 2 - 3) at 72 hours post procedure or hospital discharge (whichever comes first), per VARC-2 definitions and adjudicated by Clinical Event Committee (CEC) (for the SENTINEL subgroup)
|
30 Dyas Psot Index Procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary endpoints based on the VARC 2 endpoints & definitions will be collected peri & post procedure at discharge or 7 days post procedure whichever comes first 30 days 6 months & 12 months post index procedure unless otherwise specified below
Safety endpoints adjudicated by an independent CEC
Mean aortic valve pressure gradient at 30 days post index procedure as measured by transthoracic echocardiography TTE
ACURATE Device Performance endpoints peri & post procedure
ACURATE Device success
Additional indications of prosthetic aortic valve performance.
NYHA functional classification.
SENTINEL Procedural Success
SENTINEL deployment time for the SENTINEL subgroup
|
Peri Post procedure at discharge 30days 6Months 12 Month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
NA |