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Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events . (PATTERNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03091959
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : August 21, 2018
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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.)

Condition or disease
Cardiovascular Diseases

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll up to 300 subjects (i.e. consented) from upto 7 sites. All subjects implanted with devices (Medtronic Cardiac Rythm and Heart Failure (CRHF) implantable devices with Cardiac compass and Optivol feature) will be considered eligible for the study.

Inclusion Criteria:

  1. Subject must be greater than 18 years of age.
  2. Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
  3. Subjects between 18 years and 62 years of age must have at least 1 clinical event ,such as any major medication change, IV drug therapy, hospitalization, outside home-treatment or any similar event in the past 1 year from the date of enrollment which required a Pharmacologic intervention, associated with any of the following comorbid conditions :

    • Heart failure
    • Chronic Obstructive Pulmonary Disease (COPD)
    • Renal deficiency
    • Atrial fibrillation
    • Diabetes
  4. Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
  5. If the subject is over 62 years of age then subject can be enrolled in the study without any pre-condition of a clinical event associated with a comorbid condition.

Exclusion Criteria:

  • Subject is unwilling or unable to give informed consent

Information from the National Library of Medicine

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 identifier (NCT number): NCT03091959

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Sir Ganga Ram Hospital
New Delhi, Delhi, India, 110060
Medanta - The Medicity
Gurgaon, Haryana, India, 122001
LISIE Hospital
Cochin, Kerala, India
Fortis Escort Hospital
Delhi, India, 110025
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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Study Chair: Vinay Rajan, Phd Medtronic

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT03091959    
Other Study ID Numbers: MDT16044
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All patient identifiers will be anonymized and only the final results will be shared if there is a need.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases