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Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: September 10, 2005
Last updated: August 25, 2015
Last verified: August 2015

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.

For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

  • < 10% improvement in 6-minute hall walk, and
  • no class improvement or worsening in New York Heart Association (NYHA) scale.

For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

  • > 1 heart failure (HF) related hospitalization, and
  • no class improvement or worsening in NYHA scale.

Condition Intervention Phase
Heart Failure Device: Simultaneous VV Pacing Device: Sequential VV Pacing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular (VV) Timing in Heart Failure Patients

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • CRT Responder Rate [ Time Frame: 6 months ]
    Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.

Secondary Outcome Measures:
  • NYHA Class Progression [ Time Frame: 6 months ]
    New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.

  • 6 Minute Hall Walk Distance Test (6-MHWD) [ Time Frame: 6 months ]
    Patients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.

  • Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Randomization and 9 months ]
    Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).

Enrollment: 816
Study Start Date: January 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Simultaneous VV Pacing
Programmed to simultaneous biventricular pacing
Device: Simultaneous VV Pacing
Right ventricular and left ventricular pacing delivered simultaneously.
Active Comparator: Sequential VV Pacing
Programmed to sequential biventricular pacing
Device: Sequential VV Pacing
Right ventricular and left ventricular pacing delivered sequentially.

Detailed Description:

Study Methods

  • This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
  • Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing is eligible for enrollment.
  • At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
  • Patients are followed for a period of 6 months post randomization:

    • Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)
    • Screening/Randomization Visit (3 months post enrollment)
    • Follow-up Visit (6 months post randomization)
  • Total # of centers - 80 centers
  • Sample size - 800 patients screened for CRT non-responders

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has a standard indication for a CRT-D.
  • Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
  • Patient is geographically stable and willing to comply with the required follow-up schedule.
  • Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
  • Patients requiring a CRT-D replacement must comply with BOTH of the following:

    • > 1 HF related hospitalization
    • No class improvement or worsening in NYHA scale

Exclusion Criteria:

  • Patient's life expectancy is less than 12 months.
  • Patient has had cardiac surgery within 6 months of enrollment.
  • Patient has an epicardial ventricular lead system.
  • Patient is less than 18 years old.
  • Patient is pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00187200

United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Raul Weiss, MD Ohio State University
  More Information

Responsible Party: St. Jude Medical Identifier: NCT00187200     History of Changes
Other Study ID Numbers: CRD299
Study First Received: September 10, 2005
Results First Received: August 27, 2014
Last Updated: August 25, 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 17, 2017