NCT00632372

Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study

CRT-D Based Heart Failure Monitoring Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect and analyze electrical measurements, timing, and signals from a CRT-D device in heart failure patients who either already have an implanted left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial pressure sensor and a CRT-D device. These devices may be placed at the same time or separately (staged procedure) at the discretion of the investigator. A comparison will be made between the information gathered from the CRT-D system and the information gathered by the left atrial pressure sensor.

Detailed description

This is a multi-center feasibility study. .

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Cardiac Resynchronization Therapy	Pacing of the left ventricle to resynchronize ventricular contraction.
DEVICE	HeartPOD™ System	Left atrial pressure monitoring.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-09-01
• Completion: 2015-12-01
• First posted: 2008-03-10
• Last updated: 2020-10-12

Locations

10 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated device study