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

NCT ID: NCT01466621

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

743 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Heart Failure Pacing Induced Dyssynchrony

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Previously RV Paced

Patients who were RV paced prior to receiving a cardiac resynchronization therapy device.

No interventions assigned to this group

Non-Previously RV Paced

Patients who received a CRT device without being previously RV paced.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Allina Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan J Bank, MD

Role: PRINCIPAL_INVESTIGATOR

United Heart & Vascular Clinic

Locations

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United Heart & Vascular Clinic

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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ISRCRM110009(Boston Sci Corp)

Identifier Type: -

Identifier Source: org_study_id

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