CompletedNCT00418314Updated Feb 19, 2019Results posted

FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

An interventional study of Control and QuickOpt in Cardiac Arrhythmias and Heart Failure, sponsored by Abbott Medical Devices. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 1,647
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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).

Read the 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.

Conditions studied

Cardiac Arrhythmias
Heart Failure

Browse trials for

Arrhythmias, Cardiac 885

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 1,647 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 1,647 participants (actual)

Study arms

Experimental
QuickOpt (Treatment)
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
Device: QuickOpt
Active comparator
Control
Empiric programming or one-time optimization using a non-IEGM method.
Device: Control

Interventions

DeviceControl
Empiric programming or one-time optimization using a non-IEGM method.
DeviceQuickOpt
Frequent optimization using QuickOpt to optimize AV/PV and VV delays.

What researchers measure

Primary outcomes

Heart Failure Clinical Composite Score
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.
Time frame: 12 months

Secondary outcomes

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

Results

Posted Feb 4, 2016

Participant flow

Participant flow — Overall Study
Milestone	QuickOpt (Treatment)	Control
Started	817	830
Completed	816	828
Not completed	1	2
Withdrew: Withdrawal by subject	1	2

Outcome measures

PrimaryHeart Failure Clinical Composite Score

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.

Time frame:: 12 months
Reported as:: Number · participants

Heart Failure Clinical Composite Score
participants	QuickOpt (Treatment)	Control
Improved	551	559
Unchanged	76	86
Worsened	189	183

SecondaryAll-cause, Cardiovascular and Heart Failure Mortality;

Time frame:: 12 months
Reported as:: Number · participants

All-cause, Cardiovascular and Heart Failure Mortality;
participants	QuickOpt (Treatment)	Control
All-cause, Cardiovascular and Heart Failure Mortality;	44	42

SecondaryAll Cause, Cardiovascular and Heart Failure Hospitalization

Time frame:: 12 months
Reported as:: Number · participants

All Cause, Cardiovascular and Heart Failure Hospitalization
participants	QuickOpt (Treatment)	Control
All Cause, Cardiovascular and Heart Failure Hospitalization	294	303

Adverse events

Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
QuickOpt (Treatment)	—	120/816 (14.7%)	184/816 (22.5%)
Control	—	111/828 (13.4%)	177/828 (21.4%)

Most frequent serious events

Showing 10 of 29

Most frequent serious events
Event	QuickOpt (Treatment)	Control
Lead Dislodgment/MigrationCardiac disorders	40/816	35/828
Oversensing/UndersensingCardiac disorders	16/816	8/828
InfectionCardiac disorders	10/816	14/828
ArrhythmiasCardiac disorders	11/816	10/828
Phrenic Nerve/Diaphragmatic Nerve StimulationCardiac disorders	11/816	6/828
Elevated Pacing ThresholdsCardiac disorders	10/816	3/828
Chest pain/MICardiac disorders	7/816	9/828
DeathCardiac disorders	8/816	7/828
HematomaCardiac disorders	4/816	7/828
DVTVascular disorders	3/816	6/828

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	QuickOpt (Treatment)	Control
ArrhythmiasCardiac disorders	65/816	55/828
Heart FailureCardiac disorders	61/816	43/828
Phrenic Nerve/Diaphragmatic Nerve StimulationCardiac disorders	36/816	30/828
Lead Dislodgement/MigrationCardiac disorders	14/816	17/828
Therapy for non-ventricular rhythmCardiac disorders	5/816	16/828
Undersensing/OversensingCardiac disorders	14/816	11/828
HematomaCardiac disorders	7/816	13/828
Elevated Pacing ThresholdsCardiac disorders	10/816	3/828
SyncopeNervous system disorders	8/816	10/828
MICardiac disorders	2/816	5/828

Baseline characteristics

Date of birth missing for 1 treatment patient and 1 control patient.

Age, Categorical
Age, Categorical(Participants)	QuickOpt (Treatment)	Control	Total
<=18 years	0	0	0
Between 18 and 65 years	307	340	647
>=65 years	510	490	1000

Age, Continuous
Age, Continuous(years)	QuickOpt (Treatment)	Control	Total
Mean	66.8 ± 11	66.7 ± 11	66.7 ± 11

Sex: Female, Male
Sex: Female, Male(Participants)	QuickOpt (Treatment)	Control	Total
Female	196	238	434
Male	621	592	1213

Region of Enrollment
Region of Enrollment(participants)	QuickOpt (Treatment)	Control	Total
United States	482	487	969
Europe	282	288	570
Canada	32	35	67
Australia	17	15	32
Middle East	3	4	7
Southeast Asia	1	1	2

Study locations

2 sites

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

References and documents

Publications

Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034. PubMed 20569704 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00418314
Lead sponsor: Abbott Medical Devices
Responsible party: Sponsor
First posted: Jan 4, 2007
Start date: Oct 2006
Primary completion: Sep 2009
Completion: Sep 2009
Results posted: Feb 4, 2016
Last update: Feb 19, 2019

Study contacts

William Abraham, MD

principal investigator · Ohio State University, Columbus, OH, USA

Daniel Gras, MD

principal investigator · Nouvelles Cliniques Nantaises, Nantes, France

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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