Optimization of Cardiac Pacing Using CardioMEMS

NCT03581032 | Unknown

• 1 other identifier: 17-13
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A-Active reprogram follwed by sham

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

Device: Active reprogam

B-Sham followed by active reprogram

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

Device: Active reprogam

Interventions

Active reprogam DEVICE

Reprogram Changes in AV/PV delays

A-Active reprogram follwed by sham; B-Sham followed by active reprogram

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject Recruitment Subjects will be recruited from the CHF outpatient clinic at St Francis Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Francis Hospital, New York: lead

Study Sites (1)

St Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Related Publications (29)

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• Lee KL, Burnes JE, Mullen TJ, Hettrick DA, Tse HF, Lau CP. Avoidance of right ventricular pacing in cardiac resynchronization therapy improves right ventricular hemodynamics in heart failure patients. J Cardiovasc Electrophysiol. 2007 May;18(5):497-504. doi: 10.1111/j.1540-8167.2007.00788.x. Epub 2007 Apr 11.

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rita Jermyn, MD

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth S Haag, BSN MPA

CONTACT

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

Rita Jermyn, MD

CONTACT

516 562-6426; rita.jermyn@chsli.org

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Cardiac Therapeutics

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 10, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)