OptiVol for Precision Medical Management of Heart Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-11-20

Brief Summary

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This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.

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Detailed Description

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Subjects in this study will be randomized (2:1) to an intervention group whose medical care will be guided by data from a cardiac implantable electronic device (CIED) including information on heart rate, activity, and fluid status derived from the OptiVol monitor versus a conventional management control group. Subjects will followed for 12 months with follow up contact for 6 consecutive months and a chart review at 12 months. The study population will include patients with ischemic and non-ischemic cardiomyopathy who have had an ICD implanted per standard of care guidelines.

Conditions

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Ischemic and Non-ischemic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICM guided Medical Management Group

A pre-specified management regimen based on standard clinical practice will be provided to the study team in which medical management including medication dosing (focusing on beta-blockers and diuretics) will be monitored and modified using Cardiac Implantable Electronic Devices (CIED) and OptiVol Monitor data. Based on CIED and patient engagement data, the study team will adjust medications and dosages, and optimize activity/exercise steps.

Group Type EXPERIMENTAL

Medtronic ICD with Opti Vol-Monitor

Intervention Type DEVICE

Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD.

Conventional Management Control Group

Non-study physicians will receive CIED/OptiVol data (as in usual care) and its use and the management strategy will be left to his/her discretion. To control for patient contact, patients in the conventional management group will have the same study visits as the interventional group and will include in-person device interrogation, and documentation of any medications changes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medtronic ICD with Opti Vol-Monitor

Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 to 85 years of age on the date of randomization
* ICD implantation per guidelines for primary prevention in patients with ischemic and non-ischemic cardiomyopathy ≥3 calendar months ago.
* SMART Phone or tablet with Bluetooth capability with internet access.
* No other identifiable reversible cause explaining the left ventricular dysfunction

Exclusion Criteria

* CRT implanted
* LVEF\>45% in the last echocardiogram or other clinic imaging study performed.
* Medtronic device generator and/or device components not implanted
* Unstable clinical condition, life threatening arrhythmia
* Heart failure hospitalization within the preceding 3 calendar months
* Cognitive impairment
* Severe renal dysfunction (eGFR \< 30 ml/min/m2)
* Serious known concomitant disease with a lift expectancy of \< 12 calendar months
* Non-ambulatory NYHA class IV
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No