FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Heart Failure Clinical Trial

Official title:

FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418314
• Other study ID #: CRD378
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1647
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias
• Heart Failure

Intervention

Device:
• Control
Empiric programming or one-time optimization using a non-IEGM method.
• QuickOpt
Frequent optimization using QuickOpt to optimize AV/PV and VV delays.

Locations

Country	Name	City	State
United States	Ohio State Univeristy	Columbus	Ohio
United States	Cedars Sinai Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	All-cause, Cardiovascular and Heart Failure Mortality;		12 months
Secondary	All Cause, Cardiovascular and Heart Failure Hospitalization		12 months