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
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014