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Profiling of Implantable Cardiac Device Diagnostics trends during Clinical Events for co-morbid conditions in Indian Patients

Profiling of Implantable Cardiac Device Diagnostics trends during Clinical Events for co-morbid conditions in Indian Patients - PATTERNS

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/02/007780
Enrollment
300
Registered
2017-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- All subjects implanted with Medtronic Cardiac devices with the Cardiac Compass® and OptiVol® feature can be evaluated for the study.

Interventions

None listed

Sponsors

Medtronic Inc
Lead Sponsor
India Medtronic Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

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 a) Heart failure b) Chronic Obstructive Pulmonary Disease (COPD) c) Renal deficiency d) Atrial fibrillation e) 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

Exclusion criteria: Subject is unwilling or unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
Correlate the device measured diagnostics parameters to any clinical event in subjects which lead to a major medication change, IV drug therapy, hospitalization, outside home treatment or any similar event. This will help outline the diagnostic changes seen in such subjects prior to acute clinical events.Timepoint: Study does not have any follow up visit and only looks retrospective events of patients and this data will be evaluated at the end of six months on the study.

Secondary

MeasureTime frame
NoneTimepoint: NA

Countries

India

Contacts

Public ContactVinay Rajan

India Medtronic Pvt Ltd

vinay.rajan@medtronic.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026