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OpenTrials
Completed

NCT Number: NCT01466621

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Pacing Induced Dyssynchrony

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Death from any cause

    Time frame: Average of 4 years

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

  2. Cardiovascular Hospitalization

    Time frame: Average of 4 years

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

Secondary outcomes

  1. Change in ejection fraction

    Time frame: Approximately one year

    A measure of cardiac performance.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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