Response to Cardiac Resynchronization Therapy of Previously Right Ventricular Paced Heart Failure Patients
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|ClinicalTrials.gov Identifier: NCT01466621|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : February 24, 2016
|Condition or disease|
|Heart Failure Pacing Induced Dyssynchrony|
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|
|Actual Enrollment :||743 participants|
|Official Title:||Response to Cardiac Resynchronization Therapy of Previously Right Ventricular Paced Heart Failure Patients|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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.
- 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.
- Change in ejection fraction [ Time Frame: Approximately one year ]A measure of cardiac performance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466621
|United States, Minnesota|
|United Heart & Vascular Clinic|
|St. Paul, Minnesota, United States, 55102|
|Principal Investigator:||Alan J Bank, MD||United Heart & Vascular Clinic|