NCT00418314

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,647

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

February 4, 2016

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

January 3, 2007

Results QC Date

May 14, 2014

Last Update Submit

February 1, 2019

Conditions

Cardiac ArrhythmiasHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • All-cause, Cardiovascular and Heart Failure Mortality;

    12 months

  • All Cause, Cardiovascular and Heart Failure Hospitalization

    12 months

Study Arms (2)

QuickOpt (Treatment)

EXPERIMENTAL

Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.

Device: QuickOpt

Control

ACTIVE COMPARATOR

Empiric programming or one-time optimization using a non-IEGM method.

Device: Control

Interventions

ControlDEVICE

Empiric programming or one-time optimization using a non-IEGM method.

Control
QuickOptDEVICE

Frequent optimization using QuickOpt to optimize AV/PV and VV delays.

QuickOpt (Treatment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars Sinai Hospital

Los Angeles, California, 90048, United States

Location

Ohio State Univeristy

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 20569704DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sr. Director Clinical Studies
Organization
St. Jude Medical
tshipman@sjm.com
(408) 522-6410

Study Officials

  • William Abraham, MD

    Ohio State University, Columbus, OH, USA

    PRINCIPAL INVESTIGATOR

  • Daniel Gras, MD

    Nouvelles Cliniques Nantaises, Nantes, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

October 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 19, 2019

Results First Posted

February 4, 2016

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)