Response to Cardiac Resynchronization Therapy of Previously Right Ventricular Paced Heart Failure Patients

Completed

• Conditions: Pacing Induced Dyssynchrony; Heart Failure

• Registration Number: NCT01466621
• Lead Sponsor: Allina Health System

Brief Summary

The present proposal is designed to investigate the response to CRT in patients who were previously paced from the right ventricle (RV). The negative physiologic and structural changes associated with chronic RV pacing are well documented, but patient response following upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.

Detailed Description

The RV apex has historically been used as the site for ventricular pacing in cases of sinus node dysfunction or atrioventricular block because of its relatively accessible location for lead implantation. Initial studies showed RV pacing improved symptoms, exercise capacity, quality of life, and survival in these patients.11-13 However, more recent studies have illustrated that chronic RV pacing may actually impair LV systolic function and increase the risks of heart failure, hospitalization, and death in some patients.

The primary hypothesis is that patients upgraded to CRT from a RV pacemaker respond better than those receiving CRT as a first time device. To test this hypothesis the investigators will compare changes in cardiac size and function, and hospitalization and survival rates between the two patient groups.

The second hypothesis will investigate whether changes in septal dyssynchrony are correlated with changes in ejection fraction in previously RV paced patients. The investigators believe that the patients with the most improvement in septal dyssynchrony due to RV pacing will see the greatest improvement in LV function following upgrade to CRT. A significant correlation between change in IM-S and change in EF will support the hypothesis.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

Inclusion Criteria

• Received a CRT device between 2003 and 2009 at United Heart & Vascular Clinic
• QRS duration > 120 msec
• Pre-CRT ejection fraction =< 35%

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death from any cause	Average of 4 years	Retrospectively measure the time in days from device implant to death, if applicable.
Cardiovascular Hospitalization	Average of 4 years	Retrospectively measure the time in days from device implant to hospitalization, if applicable.

Secondary Outcome Measures

Name	Time	Method
Change in ejection fraction	Approximately one year	A measure of cardiac performance.

Trial Locations

Locations (1)

United Heart & Vascular Clinic; 🇺🇸 St. Paul, Minnesota, United States