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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187200
First received: September 10, 2005
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

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: CRT-D system
Device: Optimization of interventricular intervals
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With V-V Timing in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Secondary Outcome Measures:
  • Quality of life
  • Cardiac reverse remodeling
  • NYHA class progression
  • Left ventricular ejection fraction (LVEF)
  • HF related hospitalizations

Estimated Enrollment: 200
Study Start Date: January 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Study Methods

  • This is a prospective, randomized (simultaneous BiV pacing vs. sequential BiV pacing) study.
  • Any patient that receives an FDA approved 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 (200 randomized patients)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00187200

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

No publications provided

Responsible Party: Dr. Raul Weiss, Ohio State University
ClinicalTrials.gov Identifier: NCT00187200     History of Changes
Other Study ID Numbers: CRD299
Study First Received: September 10, 2005
Last Updated: April 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014