FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

February 1, 2019 updated by: Abbott Medical Devices
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).

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1647

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QuickOpt (Treatment)
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
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.
Empiric programming or one-time optimization using a non-IEGM method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Clinical Composite Score
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause, Cardiovascular and Heart Failure Mortality;
Time Frame: 12 months
12 months
All Cause, Cardiovascular and Heart Failure Hospitalization
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William Abraham, MD, Ohio State University, Columbus, OH, USA
  • Principal Investigator: Daniel Gras, MD, Nouvelles Cliniques Nantaises, Nantes, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CRD378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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