Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events .

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT03091959
• Lead Sponsor: 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.)

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.

Study Timeline

• Study First Submitted: 2017-02-24
• Study Start: 2017-03-02
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in device measured diagnostic parameters	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.

Trial Locations

Locations (4)

LISIE Hospital; 🇮🇳 Cochin, Kerala, India

Sir Ganga Ram Hospital; 🇮🇳 New Delhi, Delhi, India

Fortis Escort Hospital; 🇮🇳 Delhi, India

Medanta - The Medicity; 🇮🇳 Gurgaon, Haryana, India