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FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

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ClinicalTrials.gov Identifier: NCT00418314
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : February 4, 2016
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cardiac Arrhythmias
Heart Failure
Interventions Device: Control
Device: QuickOpt
Enrollment 1647
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QuickOpt (Treatment) Control
Hide Arm/Group Description Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. Empiric programming or one-time optimization using a non-IEGM method.
Period Title: Overall Study
Started 817 830
Completed 816 828
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             2
Arm/Group Title QuickOpt (Treatment) Control Total
Hide Arm/Group Description Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. Empiric programming or one-time optimization using a non-IEGM method. Total of all reporting groups
Overall Number of Baseline Participants 817 830 1647
Hide Baseline Analysis Population Description
Date of birth missing for 1 treatment patient and 1 control patient.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 817 participants 830 participants 1647 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
307
  37.6%
340
  41.0%
647
  39.3%
>=65 years
510
  62.4%
490
  59.0%
1000
  60.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 817 participants 830 participants 1647 participants
66.8  (11) 66.7  (11) 66.7  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 817 participants 830 participants 1647 participants
Female
196
  24.0%
238
  28.7%
434
  26.4%
Male
621
  76.0%
592
  71.3%
1213
  73.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 817 participants 830 participants 1647 participants
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
1.Primary Outcome
Title Heart Failure Clinical Composite Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QuickOpt (Treatment) Control
Hide Arm/Group Description:
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
Empiric programming or one-time optimization using a non-IEGM method.
Overall Number of Participants Analyzed 816 828
Measure Type: Number
Unit of Measure: participants
Improved 551 559
Unchanged 76 86
Worsened 189 183
2.Secondary Outcome
Title All-cause, Cardiovascular and Heart Failure Mortality;
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title QuickOpt (Treatment) Control
Hide Arm/Group Description:
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
Empiric programming or one-time optimization using a non-IEGM method.
Overall Number of Participants Analyzed 816 828
Measure Type: Number
Unit of Measure: participants
44 42
3.Secondary Outcome
Title All Cause, Cardiovascular and Heart Failure Hospitalization
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QuickOpt (Treatment) Control
Hide Arm/Group Description:
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
Empiric programming or one-time optimization using a non-IEGM method.
Overall Number of Participants Analyzed 816 828
Measure Type: Number
Unit of Measure: participants
294 303
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QuickOpt (Treatment) Control
Hide Arm/Group Description Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. Empiric programming or one-time optimization using a non-IEGM method.
All-Cause Mortality
QuickOpt (Treatment) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
QuickOpt (Treatment) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   120/816 (14.71%)      111/828 (13.41%)    
Cardiac disorders     
Coronary Angiogram  1/816 (0.12%)  1 1/828 (0.12%)  1
Cardiopulmonary Arrest  2/816 (0.25%)  2 1/828 (0.12%)  1
Arrhythmias  11/816 (1.35%)  12 10/828 (1.21%)  10
Cardiac Perforation  2/816 (0.25%)  2 5/828 (0.60%)  5
Thrombosis  0/816 (0.00%)  0 3/828 (0.36%)  3
Chest pain/MI  7/816 (0.86%)  10 9/828 (1.09%)  10
Coronary Sinus Dissection  1/816 (0.12%)  1 0/828 (0.00%)  0
Death  8/816 (0.98%)  8 7/828 (0.85%)  7
Device migration/malfunction  0/816 (0.00%)  0 2/828 (0.24%)  3
Elevated Pacing Thresholds  10/816 (1.23%)  10 3/828 (0.36%)  3
Erosion/Pocket Pain  4/816 (0.49%)  4 2/828 (0.24%)  2
Hematoma  4/816 (0.49%)  4 7/828 (0.85%)  7
Infection  10/816 (1.23%)  10 14/828 (1.69%)  15
Lead Dislodgment/Migration  40/816 (4.90%)  45 35/828 (4.23%)  44
Lead Fracture/Insulation Damage  3/816 (0.37%)  3 0/828 (0.00%)  0
Oversensing/Undersensing  16/816 (1.96%)  18 8/828 (0.97%)  9
Phrenic Nerve/Diaphragmatic Nerve Stimulation  11/816 (1.35%)  12 6/828 (0.72%)  7
Therapy for non-ventricular rhythm  0/816 (0.00%)  0 3/828 (0.36%)  3
Valve replacement  0/816 (0.00%)  0 2/828 (0.24%)  2
Other cardiac  4/816 (0.49%)  4 3/828 (0.36%)  3
Endocrine disorders     
Endocrine disorders  2/816 (0.25%)  2 0/828 (0.00%)  0
Gastrointestinal disorders     
Rectal Bleeding  1/816 (0.12%)  1 0/828 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint pain  3/816 (0.37%)  3 5/828 (0.60%)  5
Nervous system disorders     
CVA/TIA  2/816 (0.25%)  2 2/828 (0.24%)  2
Neurologic other  1/816 (0.12%)  1 1/828 (0.12%)  2
Respiratory, thoracic and mediastinal disorders     
Respiratory Arrest  2/816 (0.25%)  2 4/828 (0.48%)  4
Pleural Effusion  3/816 (0.37%)  4 3/828 (0.36%)  3
Respiratory other  2/816 (0.25%)  2 2/828 (0.24%)  2
Vascular disorders     
DVT  3/816 (0.37%)  3 6/828 (0.72%)  9
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
QuickOpt (Treatment) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   184/816 (22.55%)      177/828 (21.38%)    
Cardiac disorders     
Cardiopulmonary Arrest  2/816 (0.25%)  2 4/828 (0.48%)  4
Arrhythmias  65/816 (7.97%)  83 55/828 (6.64%)  63
Elevated Pacing Thresholds  10/816 (1.23%)  13 3/828 (0.36%)  3
Undersensing/Oversensing  14/816 (1.72%)  16 11/828 (1.33%)  14
Heart Failure  61/816 (7.48%)  95 43/828 (5.19%)  63
Hematoma  7/816 (0.86%)  7 13/828 (1.57%)  13
Infection  4/816 (0.49%)  5 3/828 (0.36%)  3
Lead Dislodgement/Migration  14/816 (1.72%)  16 17/828 (2.05%)  20
MI  2/816 (0.25%)  2 5/828 (0.60%)  5
Phrenic Nerve/Diaphragmatic Nerve Stimulation  36/816 (4.41%)  47 30/828 (3.62%)  34
Therapy for non-ventricular rhythm  5/816 (0.61%)  6 16/828 (1.93%)  16
Nervous system disorders     
Syncope  8/816 (0.98%)  9 10/828 (1.21%)  10
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publications and presentations proposed by participating centers should be furnished to sponsor for review and comment 30 days (manuscripts) or 7 days (abstracts) prior to submission for publication. Sponsor reserves the right to deny submission of study results if based on data owned by sponsor.
Results Point of Contact
Name/Title: Sr. Director Clinical Studies
Organization: St. Jude Medical
Phone: (408) 522-6410
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00418314     History of Changes
Other Study ID Numbers: CRD378
First Submitted: January 3, 2007
First Posted: January 4, 2007
Results First Submitted: May 14, 2014
Results First Posted: February 4, 2016
Last Update Posted: February 19, 2019