Optimization of Cardiac Pacing Using CardioMEMS
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/12/2018 |
| Start Date: | March 1, 2017 |
| End Date: | June 1, 2019 |
| Contact: | Elizabeth S Haag, BSN MPA |
| Email: | elizabeth.haag@chsli.org |
| Phone: | 516 622-4512 |
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.
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.
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.
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.
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
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