Clinical trial NCT03581032: Optimization of Cardiac Pacing Using CardioMEMS
Official title: Optimization of Cardiac Pacing Using CardioMEMS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject Recruitment Subjects will be recruited from the CHF outpatient clinic at St Francis Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary artery pressure changes
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
Study officials:
affiliation: Saint Francis Hospital
name: Rita Jermyn, MD
role: PRINCIPAL_INVESTIGATOR
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