Optimization of Cardiac Pacing Using CardioMEMS

Heart Failure Clinical Trial

Official title:

Optimization of Cardiac Pacing Using CardioMEMS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03581032
• Other study ID #: 17-13
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2018
• Source: St. Francis Hospital, New York
• Contact: Elizabeth S Haag, BSN MPA
• Phone: 516 622-4512
• Email: elizabeth.haag[@]chsli.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Active reprogam
Reprogram Changes in AV/PV delays

Locations

Country	Name	City	State
United States	St Francis Hospital	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Francis Hospital, New York

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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