Optimization of Cardiac Pacing Using CardioMEMS

• Conditions: Heart Failure
• Interventions: Device: Active reprogam

• Registration Number: NCT03581032
• Lead Sponsor: St. Francis Hospital, New York

Brief 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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-05-25
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-06
• Last Update Submitted: 2018-07-06
• Study First Posted: 2018-07-10
• Last Update Posted: 2018-07-10
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A-Active reprogram follwed by sham	Active reprogam	This arm will be randomized to have PACING device reprogramming followed by sham reprogramming
B-Sham followed by active reprogram	Active reprogam	This arm will be randomized to have sham reprogramming followed by active pacing reprogramming

Primary Outcome Measures

Name	Time	Method
Pulmonary artery pressure changes	30 days	Primary endpoint is changes in of pulmonary artery pressures within 30 days in patients who have optimization of pacing devices.

Trial Locations

Locations (1)

St Francis Hospital; 🇺🇸 Roslyn, New York, United States