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

February 23, 2016 updated by: Allina Health System
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

743

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • United Heart & Vascular Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A retrospective review of patients receiving CRT at United Heart & Vascular Clinic between 2003 and 2009.

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Previously RV Paced
Patients who were RV paced prior to receiving a cardiac resynchronization therapy device.
Non-Previously RV Paced
Patients who received a CRT device without being previously RV paced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death from any cause
Time Frame: Average of 4 years
Retrospectively measure the time in days from device implant to death, if applicable.
Average of 4 years
Cardiovascular Hospitalization
Time Frame: Average of 4 years
Retrospectively measure the time in days from device implant to hospitalization, if applicable.
Average of 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ejection fraction
Time Frame: Approximately one year
A measure of cardiac performance.
Approximately one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Alan J Bank, MD, United Heart & Vascular Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (ESTIMATE)

November 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRCRM110009(Boston Sci Corp)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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