FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

This study has been completed.
Information provided by:
St. Jude Medical Identifier:
First received: January 3, 2007
Last updated: May 22, 2010
Last verified: May 2010
The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-IEGM optimization methods).

Condition Intervention Phase
Patient Has a Standard Indication for a CRT-D
Device: Optimization of atrio-ventricular (AV/PV) and inter-ventricular (V-V) delays
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Heart Failure clinical composite score

Secondary Outcome Measures:
  • All-cause, cardiovascular and heart failure mortality; All-cause, cardiovascular and heart failure hospitalizations
  • Additional Data : 6 minute hall walk; Quality-of-life (QOL) score; Changes in AV/PV and VV delays; Time required for optimization; Frequency of atrial and ventricular arrhythmias; Percent atrial and ventricular pacing

Estimated Enrollment: 1500
Study Start Date: October 2006
Detailed Description:
  • This is a prospective, double-blinded, multicenter, randomized study
  • Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at 3, 6, 9 and 12 months
  • Patients will be randomized at enrollment to either Group 1 ("QuickOpt Group") or Group 2 ("Control Group").
  • Group 1 - The patient's device is programmed to sequential BiV pacing mode with AV/PV and VV delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits.
  • Group 2 - The patient's device is programmed to either simultaneous or sequential BiV pacing mode as per physician's discretion. The AV/PV and VV delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post implant. Any AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations.

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

Inclusion Criteria:

  • Patient meets current CRT-D indications and be implanted with an SJM CRT¬D device with VV timing and a compatible lead system.
  • Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
  • Patient has the ability to independently comprehend and complete a QOL questionnaire.

Exclusion Criteria:

  • Patient has an epicardial ventricular lead system.
  • Patient has the ability to walk ≥ 450 meters in 6 minutes
  • Patient has limited intrinsic atrial activity (≤ 40 bpm).
  • Patient has persistent or permanent AF.
  • Patient has a 2° or 3° heart block.
  • Patient's life expectancy is less than 1 year.
  • Patient is pregnant.
  • Patient is on IV inotropic agents.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00418314

United States, California
Cedars Sinai Hospital
Los Angeles, California, United States
United States, Ohio
Ohio State Univeristy
Columbus, Ohio, United States
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: William Abraham, MD Ohio State University, Columbus, OH, USA
Principal Investigator: Daniel Gras, MD Nouvelles Cliniques Nantaises, Nantes, France
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00418314     History of Changes
Other Study ID Numbers: CRD378
Study First Received: January 3, 2007
Last Updated: May 22, 2010
Health Authority: United States: Institutional Review Board processed this record on November 27, 2015