Optimization of Cardiac Pacing Using CardioMEMS

July 6, 2018 updated by: Rita Jermyn, MD, St. Francis Hospital, New York
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A-Active reprogram follwed by sham
This arm will be randomized to have PACING device reprogramming followed by sham reprogramming
Device: Active reprogam
Reprogram Changes in AV/PV delays
B-Sham followed by active reprogram
This arm will be randomized to have sham reprogramming followed by active pacing reprogramming
Device: Active reprogam
Reprogram Changes in AV/PV delays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary artery pressure changes
Time Frame: 30 days
Primary endpoint is changes in of pulmonary artery pressures within 30 days in patients who have optimization of pacing devices.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Francis Hospital, New York

Investigators

  • Principal Investigator: Rita Jermyn, MD, Saint Francis Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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