Clinical trial NCT00187200: Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Official title: RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular (VV) Timing in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
measure: CRT Responder Rate
timeFrame: 6 months
Secondary outcomes:
measure: NYHA Class Progression
timeFrame: 6 months
measure: 6 Minute Hall Walk Distance Test (6-MHWD)
timeFrame: 6 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: Randomization and 9 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Raul Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: