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

Launched by ABBOTT MEDICAL DEVICES · Sep 10, 2005

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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.