Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

Medtronic Cardiac Rhythm and Heart Failure0 sites918 target enrollmentDecember 2003

ConditionsAtrioventricular Block Heart Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrioventricular Block
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 918
Primary Endpoint: Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will:

decrease the number of hospital and clinic visits due to heart failure symptoms
extend life
delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

March 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines
•Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked
•Subject is receiving first time implant
•Subjects with heart failure but no symptoms of it (New York Heart Association \[NYHA\] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III)
•Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days
•Subject is at least 18 years old
•Subject or authorized legal guardian or representative has signed and dated the Informed Consent
•Subject is able to receive a pectoral implant
•Subject is expected to remain available for follow-up visits at the study center
•Subject is willing and able to comply with the protocol

Exclusion Criteria

•Subject has ever had a previous or has an existing device implant
•Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days
•Subjects with coronary bypass within the past 30 days
•Subjects with stent within the past 30 days
•Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement
•Subjects with a mechanical right heart valve
•Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices)
•Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager)
•Subject is pregnant, or of child bearing potential and not on a reliable form of birth control
•Subjects with a previous heart transplant

Outcomes

Primary Outcomes

Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)

Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.

Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.

Secondary Outcomes

All-Cause Mortality(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
Change in Cardiovascular Medications(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
Frequency of Adverse Events Post-randomization(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
All-Cause Mortality or Heart Failure-related Hospitalization(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
First Heart Failure Hospitalization(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
Days Hospitalized for Heart Failure(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
Change in New York Heart Association Classification(Randomization to 24 Months)
Change in Heart Failure Stage(Randomization to 24 Months)
Cardiovascular-related Healthcare Utilizations(Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
Change in Quality of Life at 6 Months(Randomization to 6 Months)
Change in Quality of Life at 12 Months(Randomization to 12 months)
Change in Quality of Life at 18 Months(Randomization to 18 Months)
Change in Quality of Life at 24 Months(Randomization to 24 Months)
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months(Randomization to 6 Months)
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months(Randomization to 12 Months)
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months(Randomization to 18 Months)
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months(Randomization to 24 Months)
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months(Randomization to 6 Months)
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months(Randomization to 12 Months)
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months(Randomization to 18 Months)
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months(Randomization to 12 Months)
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months(Randomization to 24 Months)
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months(Randomization to 6 Months)
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months(Randomization to 12 Months)
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months(Randomization to 18 Months)
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months(Randomization to 24 Months)
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months(Randomization to 24 Months)
Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months(Randomization to 6 Months)
Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months(Randomization to 12 Months)
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months(Randomization to 18 Months)
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months(Randomization to 18 Months)
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months(Randomization to 24 Months)
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months(Randomization to 18 Months)
Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months(Randomization to 18 Months)
Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months(Randomization to 24 Months)
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months(Randomization to 6 Months)
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months(Randomization to 6 Months)
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months(Randomization to 12 Months)
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months(Randomization to 24 Months)
Change in Mitral Regurgitation From Randomization to 6 Months(Randomization to 6 Months)
Change in Mitral Regurgitation From Randomization to 12 Months(Randomization to 12 Months)
Change in Mitral Regurgitation From Randomization to 18 Months(Randomization to 18 Months)
Change in Mitral Regurgitation From Randomization to 24 Months(Randomization to 24 Months)
Change in Cardiac Index From Randomization to 6 Months(Randomization to 6 Months)
Change in Cardiac Index From Randomization to 12 Months(Randomization to 12 Months)
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months(Randomization to 6 Months)
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months(Randomization to 18 Months)
Clinical Composite Score at 12 Months(Randomization to 12 Months)
CRT-P and CRT-D System Implant Success(Initial Implant Procedure)
Change in Cardiac Index From Randomization to 18 Months(Randomization to 18 Months)
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months(Randomization to 24 Months)
Clinical Composite Score at 24 Months(Randomization to 24 Months)
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months(Randomization to 12 Months)
Change in Cardiac Index From Randomization to 24 Months(Randomization to 24 Months)
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months(Randomization to 12 Months)
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months(Randomization to 6 Months)
Clinical Composite Score at 6 Months(Randomization to 6 Months)
Clinical Composite Score at 18 Months(Randomization to 18 Months)
Incidence of Ventricular Tachyarrhythmias(Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.)