Cardiovascular Diseases Clinical Trial
Official title:
Profiling of Implantable Cardiac Device Diagnostics Trends During Clinical Events for Co-morbid Conditions in Indian Patients- PATTERNS Study
The study looks to evaluate the device diagnostic data obtained from (all the Cardiac Rhythm and Heart Failure (CRHF) devices of medtronic having the Cardiac Compass® and OptiVol® diagnostic feature) these devices to identify trends during clinical events that will help early detection and prevention of cardiovascular and other comorbid conditions. (i.e. Heart failure(HF), Atrial Fibrilation,COPD, Renal dysfunction (RD), Diabetes etc.)
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.
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