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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00267098
First received: December 19, 2005
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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)

Condition Intervention
Atrioventricular Block
Heart Diseases
 Device: Cardiac Resynchronization Therapy (CRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Time to first event [ Time Frame: Enrollment to study exit ] [ Designated as safety issue: No ]
    Events include all cause mortality, heart failure related urgent care or significant increase in left ventricular end systolic volume index (LVESVI).


Secondary Outcome Measures:
  • Hazard rate for time to all cause mortality [ Time Frame: Enrollment to study exit ] [ Designated as safety issue: No ]

Enrollment: 918
Study Start Date: December 2003
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biventricular pacing Device: Cardiac Resynchronization Therapy (CRT)
Biventricular pacing
Other Names:
  • Medtronic CRT-P
  • Medtronic CRT-D
Active Comparator: Right ventricular pacing Device: Cardiac Resynchronization Therapy (CRT)
Right ventricular pacing
Other Names:
  • Medtronic CRT-P
  • Medtronic CRT-D

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267098

  Show 54 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Anne B. Curtis, MD, FHRS, FACC University at Buffalo, NY
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00267098     History of Changes
Other Study ID Numbers: 215
Study First Received: December 19, 2005
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Atrioventricular block
Cardiac Resynchronization Therapy
Pacemaker
Defibrillator
NYHA Class I, II or III Heart failure

Additional relevant MeSH terms:
Atrioventricular Block
Heart Diseases
Heart Failure
Heart Block
 Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013