NCT03581032

Optimization of Cardiac Pacing Using CardioMEMS

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: St. Francis Hospital, New York · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This study is designed to determine if a simplified technique for cardiac device reprogramming using pulmonary artery pressure (PAP) data in the acute setting holds promise to improve subjective assessments of patient quality of life (QOL), objective measurements of functional capacity, and specific systolic and diastolic echocardiographic indices.

Detailed description

The present study is designed to determine if a simplified technique for cardiac device( CRT) reprogramming using pulmonary artery pressure (PAP) via implanted CardioMEMS device data in the acute setting holds promise to improve subjective assessments of patient quality of life (QOL), objective measurements of functional capacity, and specific systolic and diastolic echocardiographic indices. The protocol requires prospective collection and analysis of echocardiographic data, subjective symptoms (Minnesota Living with Heart Failure Questionnaires), and 6-minute walk distance measurements in patients with implanted biventricular pacemakers / defibrillators who are predominantly ventricularly paced, in normal sinus rhythm, have documented NYHA class 3 Heart Failure, and have implanted pulmonary artery pressure monitors (CardioMEMS, St. Jude Medical CRMD, St. Paul, MN). Data collection will occur at presentation (rest and with ambulation), one month post-reprogramming, and two months after evaluation and / or reprogramming.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Active reprogam	Reprogram Changes in AV/PV delays

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2018-07-10
• Last updated: 2018-07-10

Locations

1 site across 1 country: United States