Roslyn, New York 11576


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03581032


Primary Contact:

Principal Investigator
Rita Jermyn, MD
Saint Francis Memorial Hospital

Elizabeth S Haag, BSN MPA
Phone: 516 622-4512
Email: elizabeth.haag@chsli.org


Backup Contact:

Email: rita.jermyn@chsli.org
Rita Jermyn, MD
Phone: 516 562-6426


Location Contact:

Roslyn, New York 11576
United States

Elizabeth Haag, BSN MPA
Phone: 516-622-4512
Email: elizabeth.haag@chsli.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.