NCT03237858

Multiple Cardiac Sensors for the Management of Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Detailed description

Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints. Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	HeartLogic ON	Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
DEVICE	HeartLogic OFF	Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON

Timeline

• Start date: 2017-08-30
• Primary completion: 2020-07-21
• Completion: 2020-07-21
• First posted: 2017-08-03
• Last updated: 2024-03-27
• Results posted: 2024-03-27

Locations

30 sites across 3 countries: United States, France, Germany

Regulatory

• FDA-regulated device study