ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimization of Cardiac Pacing Using CardioMEMS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03581032
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Rita Jermyn, MD, St. Francis Hospital, New York

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.

Condition or disease Intervention/treatment
Heart Failure Device: Active reprogam

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
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Optimization of Cardiac Pacing Using CardioMEMS
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581032


Contacts
Contact: Elizabeth S Haag, BSN MPA 516 622-4512 elizabeth.haag@chsli.org
Contact: Rita Jermyn, MD 516 562-6426 rita.jermyn@chsli.org

Locations
United States, New York
St Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag, BSN MPA    516-622-4512    elizabeth.haag@chsli.org   
Contact: Rita Jermyn, MD    516 562-6646    rita.jermyn@chsli.org   
Sponsors and Collaborators
St. Francis Hospital, New York
Investigators
Principal Investigator: Rita Jermyn, MD Saint Francis Memorial Hospital

Publications of Results:

Responsible Party: Rita Jermyn, MD, Director of Center for Cardiac Therapeutics, St. Francis Hospital, New York
ClinicalTrials.gov Identifier: NCT03581032     History of Changes
Other Study ID Numbers: 17-13
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases