FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00418314
First received: January 3, 2007
Last updated: January 5, 2016
Last verified: January 2016
  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 cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).

Condition Intervention Phase
Cardiac Arrhythmias
Heart Failure
Device: Control
Device: QuickOpt
Phase 4

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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Heart Failure Clinical Composite Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.


Secondary Outcome Measures:
  • All-cause, Cardiovascular and Heart Failure Mortality; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • All Cause, Cardiovascular and Heart Failure Hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 1647
Study Start Date: October 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QuickOpt (Treatment)
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
Device: QuickOpt
Frequent optimization using QuickOpt to optimize AV/PV and VV delays.
Active Comparator: Control
Empiric programming or one-time optimization using a non-IEGM method.
Device: Control
Empiric programming or one-time optimization using a non-IEGM method.

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 biventricular 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 inter-ventricular (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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient meets current CRT-D indications and be implanted with a St. Jude Medical (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 atrial fibrillation (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Cedars Sinai Hospital
Los Angeles, California, United States, 90048
United States, Ohio
Ohio State Univeristy
Columbus, Ohio, United States, 43210
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00418314     History of Changes
Other Study ID Numbers: CRD378 
Study First Received: January 3, 2007
Results First Received: May 14, 2014
Last Updated: January 5, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2016