Clinical trial NCT00267098: Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Official title: Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrioventricular Block
Heart Diseases
Keywords: Atrioventricular block
Cardiac Resynchronization Therapy
Pacemaker
Defibrillator
NYHA Class I, II or III Heart failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 918
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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
* Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting)
* Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent

Primary outcomes:
measure: Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: All-Cause Mortality or Heart Failure-related Hospitalization
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: First Heart Failure Hospitalization
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: Days Hospitalized for Heart Failure
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: Change in New York Heart Association Classification
timeFrame: Randomization to 24 Months
measure: Change in Heart Failure Stage
timeFrame: Randomization to 24 Months
measure: Change in Cardiovascular Medications
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: Frequency of Adverse Events Post-randomization
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: Cardiovascular-related Healthcare Utilizations
timeFrame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization.
measure: Change in Quality of Life at 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Quality of Life at 12 Months
timeFrame: Randomization to 12 months
measure: Change in Quality of Life at 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Quality of Life at 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Mitral Regurgitation From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Mitral Regurgitation From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Mitral Regurgitation From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Mitral Regurgitation From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Cardiac Index From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Cardiac Index From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Cardiac Index From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Cardiac Index From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months
timeFrame: Randomization to 6 Months
measure: Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months
timeFrame: Randomization to 12 Months
measure: Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months
timeFrame: Randomization to 18 Months
measure: Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months
timeFrame: Randomization to 24 Months
measure: Clinical Composite Score at 6 Months
timeFrame: Randomization to 6 Months
measure: Clinical Composite Score at 12 Months
timeFrame: Randomization to 12 Months
measure: Clinical Composite Score at 18 Months
timeFrame: Randomization to 18 Months
measure: Clinical Composite Score at 24 Months
timeFrame: Randomization to 24 Months
measure: CRT-P and CRT-D System Implant Success
timeFrame: Initial Implant Procedure
measure: Incidence of Ventricular Tachyarrhythmias
timeFrame: Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Peoria
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Glendale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Park Ridge
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Davenport
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Lacombe
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis Park
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Camden
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Bay Shore
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: West Islip
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Danville
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Ephrata
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Kingsport
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: University at Buffalo, NY
name: Anne B. Curtis, MD, FHRS, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curtis AB, Worley SJ, Chung ES, Li P, Christman SA, St John Sutton M. Improvement in Clinical Outcomes With Biventricular Versus Right Ventricular Pacing: The BLOCK HF Study. J Am Coll Cardiol. 2016 May 10;67(18):2148-2157. doi: 10.1016/j.jacc.2016.02.051.
citation: St John Sutton M, Plappert T, Adamson PB, Li P, Christman SA, Chung ES, Curtis AB. Left Ventricular Reverse Remodeling With Biventricular Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Heart Failure in the BLOCK HF Trial. Circ Heart Fail. 2015 May;8(3):510-8. doi: 10.1161/CIRCHEARTFAILURE.114.001626. Epub 2015 Feb 19.
citation: Curtis AB, Worley SJ, Adamson PB, Chung ES, Niazi I, Sherfesee L, Shinn T, Sutton MS; Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. 2013 Apr 25;368(17):1585-93. doi: 10.1056/NEJMoa1210356.