Optimization of Cardiac Pacing Using CardioMEMS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization of Cardiac Pacing Using CardioMEMS

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Active reprogam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have implanted PPM, ICD, or CRT devices and CardioMEMS Patients can ambulate for 6 minutes and lay on a flat surface Patients are paced > 95% of the time Patients are not in acute CHF and are on a stable medication regimen Patients have adequate echocardiographic windows Patients can consent independently Exclusion Criteria: Patients with poor echocardiographic acoustical resolution. Patients with congenital heart disease. Patients with mechanical aortic or mitral valve replacements. Patients with significant mitral annular calcification. Patients with irregular heart rates: atrial fibrillation, supraventricular tachycardia, atrial premature contractions, and ventricular arrhythmia that would preclude data acquisition. Patients unable to remain still secondary to movement disorders or agitation. Inpatient status Patients with poorly controlled HTN (SBP>160/90
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A-Active reprogram follwed by sham<br>This arm will be randomized to have PACING device reprogramming followed by sham reprogramming | Device: Active reprogam<br>* Reprogram Changes in AV/PV delays<br>|
| B-Sham followed by active reprogram<br>This arm will be randomized to have sham reprogramming followed by active pacing reprogramming | Device: Active reprogam<br>* Reprogram Changes in AV/PV delays<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary artery pressure changes | Primary endpoint is changes in of pulmonary artery pressures within 30 days in patients who have optimization of pacing devices. | 30 days |