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FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00418314
First received: January 3, 2007
Last updated: May 22, 2010
Last verified: May 2010
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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.
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418314

Locations
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 23, 2013