Recruiting

CardioMEMS

Sponsor:

St. Francis Hospital, New York

Code:

NCT03581032

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Active reprogam

Study Details

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.

Conditions

Heart Failure

Study ID

NCT03581032

Start date

Mar 1, 2017

Status verified date

Jul, 2018

Completion date

Jun 1, 2019

Anticipated

Primary completion date

Mar 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

A-Active reprogram follwed by sham

This arm will be randomized to have PACING device reprogramming followed by sham reprogramming

B-Sham followed by active reprogram

This arm will be randomized to have sham reprogramming followed by active pacing reprogramming

Interventions

Active reprogam

Reprogram Changes in AV/PV delays

Primary outcome measure

  • Pulmonary artery pressure changes [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Elizabeth S Haag, BSN MPA

516 622-4512elizabeth.haag@chsli.org

Rita Jermyn, MD

516 562-6426rita.jermyn@chsli.org

Locations

St Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Elizabeth Haag, BSN MPA

516-622-4512elizabeth.haag@chsli.org

Rita Jermyn, MD

516 562-6646rita.jermyn@chsli.org

More Information

Sponsor

St. Francis Hospital, New York

Last update posted

Jul 10, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Francis Hospital, New York on 2018-07-10.