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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2018/03/012847 |
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Date of registration:
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26-03-2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The International Society for Heart and Lung Transplantation Registry for Mechanically Heart
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Scientific title:
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ISHLT Mechanically Assisted Circulatory Support Registry - IMACS |
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Date of first enrolment:
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16-04-2018 |
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Target sample size:
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1000 |
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Recruitment status: |
Not Yet Recruiting |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22454 |
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Study type:
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Observational |
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Study design:
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Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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Australia
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Austria
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Azerbaijan
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Belarus
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Belgium
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Brazil
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Canada
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Colombia
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Czech Republic
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Denmark
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Egypt
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Finland
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France
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Ireland
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Israel
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Italy
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Japan
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Kazakhstan
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Netherlands
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New Zealand
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Norway
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Poland
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Saudi Arabia
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Singapore
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Slovakia
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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United States of America
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Contacts
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Name:
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Dr Julius Punnen
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Address:
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Narayana Institute of Cardiac Sciences
258/A, Bommasandra Industrial area, Anekal Taluk, Bangalore
560099
Bangalore Rural, KARNATAKA
India |
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Telephone:
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9980072785 |
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Email:
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jpunnen@hotmail.com |
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Affiliation:
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Narayana Hrudayalaya Ltd |
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Name:
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Dr Varun Shetty
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Address:
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Narayana Institute of Cardiac Sciences
258/A, Bommasandra Industrial area, Anekal Taluk, Bangalore
560099
Bangalore Rural, KARNATAKA
India |
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Telephone:
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9980072785 |
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Email:
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jpunnen@hotmail.com |
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Affiliation:
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Narayana Hrudayalaya Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients who receive a Durable Mechanical Circulatory Support Device will be included n the study
Exclusion criteria: Patients who receive a non-durable mechanically circulatory support device (MCSD. There is no exclusion for age, gender, race, ethnicity, or any other demographic limit.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Heart failure, Durable Left ventricular assisted device
Health Condition 2: I509- Heart failure, unspecified
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Intervention(s)
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Intervention1: NIL: NIL
Control Intervention1: Nil: Nil
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Primary Outcome(s)
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1. Improved outcomes from new techniques and devices
2. Facilitate accelerated evaluation of new devices
3. Development of international standards for MCS therapyTimepoint: 1 month, 3 month, and every 6 month
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Secondary Outcome(s)
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NoneTimepoint: None
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Source(s) of Monetary Support
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Narayana Hrudayalaya Ltd
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Ethics review
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Status: Approved
Approval date: 02/09/2017
Contact:
Narayana Health Academic Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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