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CTRI Number  CTRI/2019/06/019717 [Registered on: 17/06/2019] Trial Registered Prospectively
Last Modified On: 14/06/2019
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Data collection registry to assess the performance of Confirm RxTM Insertable Cardiac Monitor (ICM) and system over a 12 month period 
Scientific Title of Study   Prospective, Single Arm, multi center registry study of subjects with a Confirm Rx Insertable Cardiac Monitor SMART Registry. 
Trial Acronym  Confirm Rx SMART Registry 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03505801  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prakash Hazra 
Designation  HOD., Dept. of Intervention Cardiology  
Affiliation  Advance Medicare Research Institute (AMRI) Hospital, Kolkata 
Address  Dept. of Cardiology, Advance Medicare Research Institute (AMRI) Hospital, P-4&5, Gariahat Road Block-A, Scheme-L11, Kolkata

Kolkata
WEST BENGAL
700029
India 
Phone    
Fax    
Email  prakashhazra@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Anand  
Designation  Sr. Manager- Clinical Operations  
Affiliation  St. Jude Medical [Abbott] 
Address  Plot no 100, Okhla Industrial Estate, Phase-III,

New Delhi
DELHI
110020
India 
Phone  01142600155  
Fax    
Email  sumit.anand@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Anand  
Designation  Sr. Manager- Clinical Operations  
Affiliation  St. Jude Medical [Abbott] 
Address  Plot no 100, Okhla Industrial Estate, Phase-III,

New Delhi
DELHI
110020
India 
Phone  01142600155  
Fax    
Email  sumit.anand@abbott.com  
 
Source of Monetary or Material Support  
St Jude Medical Abbott  
 
Primary Sponsor  
Name  St Jude Medical Abbott  
Address  Plot no. 100, Okhla Industrial Estate, Phase-III, Delhi-110020 
Type of Sponsor  Other [Medical Device Company ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Republic of Korea
Algeria
Argentina
Austria
Belgium
Canada
Germany
Italy
Japan
Kuwait
Latvia
Netherlands
Portugal
South Africa
Spain
Switzerland
United Kingdom  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prakash Hazra  Advance Medicare Research Institute (AMRI) Hospital  Advance Medicare Research Institute (AMRI) Hospital, P-4&5, Gariahat Road Block-A, Scheme-L11, Kolkata
Kolkata
WEST BENGAL 		 919830077307

prakashhazra@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AMRI Hospital, west Bengal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I48||Atrial fibrillation and flutter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Confirm Rxâ„¢ICM device  The Confirm Rxâ„¢ Insertable Cardiac Monitor (ICM) device and system is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. Enrolled subjects will be followed-up to collect data through 12 months post insertion procedure.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Eligible subjects will meet all of the following:
1. Have an approved indication for continuous arrhythmia monitoring with an ICM.
2. Have a cellular phone or the ability or willing to use a St. Jude Medical mobile transmitter that is compatible with the MyMerlin™ App and able to communicate with the Confirm RxTM ICM device. If a subject doesn’t have a cell phone or loses their cell phone, then the site can provide a St. Jude Medical mobile transmitter to the subject. The study will not provide cell phones.
3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law. 
 
ExclusionCriteria 
Details  Subjects will be excluded if they meet any of the following:
1. Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study.
3. Have a life expectancy of less than 1 year due to any condition.
4. Have a previous ICM placement. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint is the freedom from device SADEs and serious procedure related SAEs through 1 month post insertion procedure.  1-, 6- and 12-Month 
 
Secondary Outcome  
Outcome  TimePoints 
The following secondary endpoints to meet the PMCF requirements will be reported:
• Freedom from device SADEs and procedure related SAEs through 12 months post insertion procedure.
• R wave amplitude at scheduled follow-up intervals through 12 months post insertion procedure. 		 1-, 6- and 12-Month  
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/06/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  24/04/2018 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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)?  

Brief Summary  

This clinical investigation is intended to collect real world data to assess the safety and performance of the Confirm RxTM Insertable Cardiac Monitor (ICM) and system over a 12-month period.  The Confirm RxTM SMART Registry will be conducted in accordance with this CIP and applicable regulations.  

The primary objective is to evaluate the freedom from serious adverse device effects (SADEs) and procedure related serious adverse events (SAEs) through 1-month post insertion procedure.  Additionally, the study will assess the impact to quality of life in subjects inserted with the Confirm RxTM ICM device and provide feedback on the user experience with the Confirm RxTM ICM device and system. 

The clinical study will be conducted in approximately 100 centers worldwide. Up to 2000 subjects will be enrolled in this study. Enrollment in the study is expected to take approximately 18 months.  The total duration of the clinical investigation is expected to be approximately 30 months.  

 
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