Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events . (PATTERNS)
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|ClinicalTrials.gov Identifier: NCT03091959|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : August 21, 2018
|Condition or disease|
This is a multi-center, non-randomized, Non-interventional, data collection study with no subject follow-up visits required. Subjects will be enrolled and exited from the study during the same study visit.
The final analysis on the study will occur when 50 clinical events are reported on the study.All Medtronic implantable Cardiac Rhythm and Heart Failure devices with the Cardiac Compass® and OptiVol® feature which are commercially available at the start of the registry or become commercially available during the course of the registry and used within its intended use, may be included in the study.
After obtaining the informed consent patients will be interviewed to complete the "patient interview questionnaire". The study team will review medical records and complete the "Medical Record Review" form as completely as possible. The device will then be interrogated to download the cardiac Compass® report in a "save-to-disk" file and print the cardiac Compass® report for the PI or the designated clinician from the study team for review. The "device interrogation questionnaire" will then be discussed with the patient for specific events identified on the Cardiac Compass® report in order to determine possible explanations and fill out the questionnaire as completely as possible. After collection of all the study related data the patient will be exited on the same visit, so a followup visit is not required in the study.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Profiling of Implantable Cardiac Device Diagnostics Trends During Clinical Events for Co-morbid Conditions in Indian Patients- PATTERNS Study|
|Actual Study Start Date :||March 2, 2017|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
- Change in device measured diagnostic parameters [ Time Frame: The diagnostic parameters can be stored within device for upto 12 months and this will be evaluated once the patient is interrogated and the report analyzed. ]Determine a combined diagnostic index that can identify patient at risk for a clinical event Determine the number of device measured diagnostic parameter that change prior to any clinical events associated with at least one of the comorbid conditions, including worsening heart failure, COPD, diabetes, and renal failure, which require major medication change, IV drug therapy, hospitalization, outside home treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091959
|Sir Ganga Ram Hospital|
|New Delhi, Delhi, India, 110060|
|Medanta - The Medicity|
|Gurgaon, Haryana, India, 122001|
|Cochin, Kerala, India|
|Fortis Escort Hospital|
|Delhi, India, 110025|
|Study Chair:||Vinay Rajan, Phd||Medtronic|