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

NCT00267098 | Completed Results DMC

• 1 other identifier: 215
• Study Type: interventional
• Target: 918
• Locations: 2 countries
• Sites: 54

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)

Conditions

Atrioventricular Block; Heart Diseases

Keywords

Atrioventricular block; Cardiac Resynchronization Therapy; Pacemaker; Defibrillator; NYHA Class I, II or III Heart failure

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (60)

• All-Cause Mortality

  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.

Study Arms (2)

Biventricular pacing

EXPERIMENTAL

Device: Cardiac Resynchronization Therapy (CRT)

Right ventricular pacing

ACTIVE COMPARATOR

Device: Cardiac Resynchronization Therapy (CRT)

Interventions

Cardiac Resynchronization Therapy (CRT) DEVICE

Biventricular pacing

Also known as: Medtronic CRT-P, Medtronic CRT-D

Biventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (54)

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Anchorage, Alaska, United States

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Peoria, Arizona, United States

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Little Rock, Arkansas, United States

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Glendale, California, United States

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Long Beach, California, United States

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Colorado Springs, Colorado, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Park Ridge, Illinois, United States

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Rockford, Illinois, United States

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Davenport, Iowa, United States

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Lexington, Kentucky, United States

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Lacombe, Louisiana, United States

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Boston, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Petoskey, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Camden, New Jersey, United States

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Hackensack, New Jersey, United States

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Ridgewood, New Jersey, United States

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Bay Shore, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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West Islip, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Danville, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Ephrata, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Providence, Rhode Island, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Related Publications (5)

• 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.

  PMID: 37671601 DERIVED

• 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.

  PMID: 36700426 DERIVED

• 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.

  PMID: 27151347 DERIVED

• 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.

  PMID: 25697851 DERIVED

• 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.

  PMID: 23614585 DERIVED

MeSH Terms

Conditions

Atrioventricular Block; Heart Diseases

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Results Point of Contact

• Title: BLOCK HF Clinical Trial Leader
• Organization: Medtronic CRDM Clinical

medtroniccrmtrials@medtronic.com

763-526-2729

Study Officials

• Anne B. Curtis, MD, FHRS, FACC

  University at Buffalo, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 20, 2005
• Study Start: December 1, 2003
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-02

Locations

US (51); CA (3)