Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
NCT ID: NCT00267098
Last Updated: 2014-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
918 participants
INTERVENTIONAL
2003-12-31
2013-03-31
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Biventricular pacing
Cardiac Resynchronization Therapy (CRT)
Biventricular pacing
Right ventricular pacing
Cardiac Resynchronization Therapy (CRT)
Right ventricular pacing
Interventions
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Cardiac Resynchronization Therapy (CRT)
Biventricular pacing
Cardiac Resynchronization Therapy (CRT)
Right ventricular pacing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Anne B. Curtis, MD, FHRS, FACC
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo, NY
Locations
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Anchorage, Alaska, United States
Peoria, Arizona, United States
Little Rock, Arkansas, United States
Glendale, California, United States
Long Beach, California, United States
Colorado Springs, Colorado, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Park Ridge, Illinois, United States
Rockford, Illinois, United States
Davenport, Iowa, United States
Lexington, Kentucky, United States
Lacombe, Louisiana, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Petoskey, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Saint Louis Park, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Camden, New Jersey, United States
Hackensack, New Jersey, United States
Ridgewood, New Jersey, United States
Bay Shore, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
West Islip, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Danville, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Ephrata, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Providence, Rhode Island, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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Fudim M, Dalgaard F, Friedman DJ, Abraham WT, Cleland JGF, Curtis AB, Gold MR, Kutyifa V, Linde C, Ali-Ahmed F, Tang A, Olivas-Martinez A, Inoue LYT, Al-Khatib SM, Sanders GD. Comorbidities and clinical response to cardiac resynchronization therapy: Patient-level meta-analysis from eight clinical trials. Eur J Heart Fail. 2024 Apr;26(4):1039-1046. doi: 10.1002/ejhf.3029. Epub 2023 Sep 15.
Friedman DJ, Al-Khatib SM, Dalgaard F, Fudim M, Abraham WT, Cleland JGF, Curtis AB, Gold MR, Kutyifa V, Linde C, Tang AS, Ali-Ahmed F, Olivas-Martinez A, Inoue LYT, Sanders GD. Cardiac Resynchronization Therapy Improves Outcomes in Patients With Intraventricular Conduction Delay But Not Right Bundle Branch Block: A Patient-Level Meta-Analysis of Randomized Controlled Trials. Circulation. 2023 Mar 7;147(10):812-823. doi: 10.1161/CIRCULATIONAHA.122.062124. Epub 2023 Jan 26.
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.
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.
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.
Other Identifiers
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215
Identifier Type: -
Identifier Source: org_study_id
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