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

NCT ID: NCT00187200

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 816 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2010-04-30

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simultaneous VV Pacing

Programmed to simultaneous biventricular pacing

Group Type: ACTIVE_COMPARATOR

Simultaneous VV Pacing

Intervention Type: DEVICE

Right ventricular and left ventricular pacing delivered simultaneously.

Sequential VV Pacing

Programmed to sequential biventricular pacing

Group Type: ACTIVE_COMPARATOR

Sequential VV Pacing

Intervention Type: DEVICE

Right ventricular and left ventricular pacing delivered sequentially.

Interventions

Simultaneous VV Pacing

Right ventricular and left ventricular pacing delivered simultaneously.

Intervention Type: DEVICE

Sequential VV Pacing

Right ventricular and left ventricular pacing delivered sequentially.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raul Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

CRD299

Identifier Type: -

Identifier Source: org_study_id