Iowa City, Iowa 52242


Purpose:

This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.


Study summary:

This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.


Criteria:

Inclusion Criteria: - Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months. - LVEF < 35% by trans-thoracic echocardiogram assessment - Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities* - Normal sinus rhythm at enrollment - RBBB with QRS duration >120 msec on 12 lead surface EKG. - PR interval <250 msec on 12 lead surface EKG - Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion) Exclusion Criteria: - Age younger than 18 years old - Pregnancy - Acute Myocardial infarction within 6 months of entry into the study - Inotrope dependent heart failure condition - Left ventricular assist device or heart transplantation - Any other known conditions other than heart failure that could limit survival to < 6 months. - Atrial fibrillation or flutter burden >10% of the time within the last 6 months - Atrioventricular node disease that requires ventricular pacemaker support >10% of the time


NCT ID:

NCT02441101


Primary Contact:

Study Chair
Michael C Giudici, MD
University of Iowa

Michael C Giudici, MD
Phone: 319-353-8153
Email: michael-c-giudici@uiowa.edu


Backup Contact:

Email: belal-alkhiami@uiowa.edu
Belal O Al Khiami, MBBS
Phone: 319-353-8153


Location Contact:

Iowa City, Iowa 52242
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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