NCT04206501

OptiVol for Precision Medical Management of Heart Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Ischemic and Non-ischemic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-02-05
• Primary completion: 2022-11-01
• Completion: 2022-11-20
• First posted: 2019-12-20
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study