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Clinical Trials/NCT01466621
NCT01466621
Completed
Not Applicable

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

Allina Health System1 site in 1 country743 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Allina Health System
Enrollment
743
Locations
1
Primary Endpoint
Death from any cause
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
June 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Death from any cause

Time Frame: Average of 4 years

Retrospectively measure the time in days from device implant to death, if applicable.

Cardiovascular Hospitalization

Time Frame: Average of 4 years

Retrospectively measure the time in days from device implant to hospitalization, if applicable.

Secondary Outcomes

  • Change in ejection fraction(Approximately one year)

Study Sites (1)

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