N/A Completed N=1,647 Randomized Double-blind Treatment

FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Cardiac arrhythmias · Heart Failure

Source: ClinicalTrials.gov NCT00418314 ↗

Enrolled (actual)

1,647

Serious AEs

14.1%

Results posted

Feb 2016

Primary outcomePrimary: Heart Failure Clinical Composite Score — 551; 559; 76; 86 participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Failure Clinical Composite Score	551; 559; 76; 86; 189; 183	—
SECONDARY All-cause, Cardiovascular and Heart Failure Mortality;	44; 42	—
SECONDARY All Cause, Cardiovascular and Heart Failure Hospitalization	294; 303	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00418314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.