Optimization of Cardiac Pacing Using CardioMEMS

St. Francis Hospital, New York

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Active reprogam

Study type: Observational

Funder types: Other

Identifiers

NCT03581032

17-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients have implanted PPM, ICD, or CRT devices and CardioMEMS
2. Patients can ambulate for 6 minutes and lay on a flat surface
3. Patients are paced > 95% of the time
4. Patients are not in acute CHF and are on a stable medication regimen
5. Patients have adequate echocardiographic windows
6. Patients can consent independently

Exclusion criteria

1. Patients with poor echocardiographic acoustical resolution.
2. Patients with congenital heart disease.
3. Patients with mechanical aortic or mitral valve replacements.
4. Patients with significant mitral annular calcification.
5. Patients with irregular heart rates: atrial fibrillation, supraventricular tachycardia, atrial premature contractions, and ventricular arrhythmia that would preclude data acquisition.
6. Patients unable to remain still secondary to movement disorders or agitation.
7. Inpatient status
8. Patients with poorly controlled HTN (SBP>160/90

Trial design

30 participants in 2 patient groups

A-Active reprogram follwed by sham

Description:

This arm will be randomized to have PACING device reprogramming followed by sham reprogramming

Treatment:

Device: Active reprogam

B-Sham followed by active reprogram

Description:

This arm will be randomized to have sham reprogramming followed by active pacing reprogramming

Treatment:

Device: Active reprogam