| CTRI Number |
CTRI/2022/02/040484 [Registered on: 22/02/2022] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Medtronic Cardiac Ablation (Freezes the Heart Tissue to help break electrical signals) Post-Market Study platform which looks at “real-world†product safety and patient clinical outcomes. |
|
Scientific Title of Study
|
To Treat Cardiac Arrhythmias Patients with Cardiac Cryoablation Catheters in India- "Cryo Global Registry study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT02752737 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Sr. Manager, Clinical and Medical Affairs APAC Emerging and Frontier 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
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-22-48810700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Sr. Manager, Clinical and Medical Affairs APAC Emerging and Frontier 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
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-22-48810700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Rajan |
| Designation |
Sr. Manager, Clinical and Medical Affairs APAC Emerging and Frontier 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
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-22-48810700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt Ltd
1261,Solitaire Corporate Park, Bldg No 12, 6th Floor,
Andheri-Ghatkopar Link Road,
Andheri (East), Mumbai 400093, India
Contact Number - 91-22-48810700 |
|
|
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 Contact Number - 91-22-48810700 |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Belgium
Brunei Darussalam
Argentina
Austria
Chile
China
Colombia
Czech Republic
Germany
Greece
Hungary
Iceland
India
Indonesia
Italy
Japan
Kazakhstan
Kuwait
Malaysia
Mexico
Oman
Philippines
Poland
Portugal
Republic of Korea
Russian Federation
Saudi Arabia
Serbia
Singapore
Slovakia
South Africa
Spain
Switzerland
Taiwan
Thailand
United Arab Emirates
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthigesan A M |
Apollo Hospital |
21, Greams Lane, Off Greams Road, Chennai-600006, Tamil Nadu
Chennai
TAMIL NADU |
8056172261
amkgesan@hotmail.com |
| Dr Calambur Narasimhan |
Asian Institute of Gastroenterology |
Survey No 136, Plot No 2/3/4/5, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
040-23378888
calambur@hotmail.com |
| Dr Praveen Sreekumar |
Aster Medcity |
Kuttisahib Road Cheranalloor,
South Chittoor,
Kochi, Kerala- 682027
Kollam
KERALA |
4846699999
praveen_sreekumar2004@yahoo.com |
| Dr J S Makkar |
Eternal Heart Hospital |
3A, Jagatpura Rd, near Jawahar Circle, Chainpura, Malviya Nagar, Jaipur, Rajasthan 302017
Jaipur
RAJASTHAN |
01415174000
drjsm@hotmail.com |
| Dr Balbir Singh |
Max Hospital |
Max Super Speciality Hospital, East Block, (A Unit of Devki Devi Foundation),
2, Press Enclave Road, Saket, New Delhi-110070, India.
New Delhi
DELHI |
9310015172
drbalbirs@gmail.com |
| Dr Karthikeya Bhargava |
Medanta - The Medicity |
Sector 38, Gurugram,
Haryana – 122001, India
Gurgaon
HARYANA |
1244141414
Kartikeya.Bhargava@Medanta.org |
| Dr Arun Gopi |
Metromed International Cardiac Centre |
Metromed International Cardiac Centre, Thondayad, Bypass Road, opposite Mahindra Trucks and Bus, Palazhi, Kozhikode, Kerala 673014
Kozhikode
KERALA |
8921673316
abhijithclassicozz@gmail.com |
| Dr Narayanan Namboodiri |
Sree Chitra Tirunal Institute For Medical Science and Technology |
Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA |
9495866194
kknnamboodiri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Apollo Hospital |
Approved |
| Institutional Ethics Committee - Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee - Aster Medcity |
Approved |
| Institutional Ethics Committee - Devki Devi Foundation |
Approved |
| Institutional Ethics Committee - Eternal Heart Hospital |
Approved |
| Institutional Ethics Committee - Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Approved |
| Medanta Institutional Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject is ≥ 18 years of age or minimum age as required by local regulations
2. Planned procedure using commercially available Arctic Frontâ„¢ and Freezorâ„¢ Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Frontâ„¢ Cardiac Cryoablation Catheter System)
3. Willing to comply with study requirements and give informed consent (IC) (defined as legally effective, documented confirmation of a subject’s voluntary agreement to participate in
this clinical study) or authorization per institution and geographical requirements
|
|
| ExclusionCriteria |
| Details |
1. Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
2. Subject with exclusion criteria required by local law
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Freedom from atrial fibrillation (AF)
recurrence using the Arctic Frontâ„¢ Family of Cardiac Cryoablation Catheters
2.Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT) recurrence using the Arctic Frontâ„¢ Family of Cardiac Cryoablation Catheters
3.Freedom from arrhythmias treated using the Freezorâ„¢ Family of Cardiac Cryoablation Catheters
4. Device and procedure related adverse events for
cryoablation using the Arctic Frontâ„¢ Cardiac Cryoablation
Catheter System |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Characteristics of the cryoablation procedure
2. Change in quality of life (QoL)
3. Characteristics of global Standard of Care (SOC) for ablation patients receiving a cryoablation
4. All cause, cardiovascular, and arrhythmia related
rehospitalization rates post-ablation |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="3500"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
Modification(s)
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/03/2022 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
02/05/2016 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Arctic FrontTM Family of Cardiac CryoAblation Catheters are used for the treatment of patients with atrial fibrillation (AF). These catheters facilitate anatomical isolation of the pulmonary veins from the left atrium with the application of a 23mm or 28mm cryoballoon at the pulmonary vein ostium. The cryoballoon ablates with minimal disruption of the endothelium, creates relatively discrete lesions, and preserves the myocardial architecture, followed by replacement with fibrous tissue through the Joule-Thomson effect. The Freezorâ„¢ Family of Cardiac Cryoablation Catheters are used for the focal cryoablation of cardiac tissue to treat cardiac arrhythmias. Approved indications for use for each market-released product are defined in the respective labeling for each geography. This clinical study has been designed to provide valid scientific evidence on the safety and effectiveness of the Arctic Frontâ„¢ and Freezorâ„¢ Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Frontâ„¢ Cardiac Cryoablation Catheter System) in a global setting. Previous clinical studies have reported on safety and efficacy of these devices. Medtronic has published numerous studies including the STOP AF Post-Approval Study, Cryo4Persistent AF, ICY-AVNRT, and STOP AF First. There are also several investigator-initiated single center publications.
The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this registry is to describe clinical performance and safety data in a broad patient population treated with Arctic Frontâ„¢ Cardiac Cryoablation Catheter System. To assess clinical performance and safety of the system, study objectives will estimate 12-month efficacy and procedural safety. Additionally, study objectives will characterize the ablation procedure, Quality of Life (QoL), and global standard of care for AF ablation patients having cryoablation.
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