Trial Outcomes & Findings for FREEDOM - A Frequent Optimization Study Using the QuickOpt Method (NCT NCT00418314)
NCT ID: NCT00418314
Last Updated: 2019-02-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1647 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-19
Participant Flow
Participant milestones
| Measure |
QuickOpt (Treatment)
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
Overall Study
STARTED
|
817
|
830
|
|
Overall Study
COMPLETED
|
816
|
828
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
QuickOpt (Treatment)
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Baseline characteristics by cohort
| Measure |
QuickOpt (Treatment)
n=817 Participants
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
n=830 Participants
Empiric programming or one-time optimization using a non-IEGM method.
|
Total
n=1647 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
307 Participants
n=99 Participants
|
340 Participants
n=107 Participants
|
647 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
510 Participants
n=99 Participants
|
490 Participants
n=107 Participants
|
1000 Participants
n=206 Participants
|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 11 • n=99 Participants
|
66.7 years
STANDARD_DEVIATION 11 • n=107 Participants
|
66.7 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=99 Participants
|
238 Participants
n=107 Participants
|
434 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
621 Participants
n=99 Participants
|
592 Participants
n=107 Participants
|
1213 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
482 participants
n=99 Participants
|
487 participants
n=107 Participants
|
969 participants
n=206 Participants
|
|
Region of Enrollment
Europe
|
282 participants
n=99 Participants
|
288 participants
n=107 Participants
|
570 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
32 participants
n=99 Participants
|
35 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
17 participants
n=99 Participants
|
15 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
Middle East
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Southeast Asia
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
QuickOpt (Treatment)
n=816 Participants
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
n=828 Participants
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
Heart Failure Clinical Composite Score
Worsened
|
189 participants
|
183 participants
|
|
Heart Failure Clinical Composite Score
Improved
|
551 participants
|
559 participants
|
|
Heart Failure Clinical Composite Score
Unchanged
|
76 participants
|
86 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per protocol
Outcome measures
| Measure |
QuickOpt (Treatment)
n=816 Participants
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
n=828 Participants
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
All-cause, Cardiovascular and Heart Failure Mortality;
|
44 participants
|
42 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
QuickOpt (Treatment)
n=816 Participants
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
n=828 Participants
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
All Cause, Cardiovascular and Heart Failure Hospitalization
|
294 participants
|
303 participants
|
Adverse Events
QuickOpt (Treatment)
Serious events: 120 serious events
Other events: 184 other events
Deaths: 0 deaths
Control
Serious events: 111 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QuickOpt (Treatment)
n=816 participants at risk
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
n=828 participants at risk
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
Cardiac disorders
Coronary Angiogram
|
0.12%
1/816 • Number of events 1
|
0.12%
1/828 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
0.25%
2/816 • Number of events 2
|
0.12%
1/828 • Number of events 1
|
|
Cardiac disorders
Arrhythmias
|
1.3%
11/816 • Number of events 12
|
1.2%
10/828 • Number of events 10
|
|
Cardiac disorders
Cardiac Perforation
|
0.25%
2/816 • Number of events 2
|
0.60%
5/828 • Number of events 5
|
|
Cardiac disorders
Thrombosis
|
0.00%
0/816
|
0.36%
3/828 • Number of events 3
|
|
Cardiac disorders
Chest pain/MI
|
0.86%
7/816 • Number of events 10
|
1.1%
9/828 • Number of events 10
|
|
Cardiac disorders
Coronary Sinus Dissection
|
0.12%
1/816 • Number of events 1
|
0.00%
0/828
|
|
Cardiac disorders
Death
|
0.98%
8/816 • Number of events 8
|
0.85%
7/828 • Number of events 7
|
|
Cardiac disorders
Device migration/malfunction
|
0.00%
0/816
|
0.24%
2/828 • Number of events 3
|
|
Cardiac disorders
Elevated Pacing Thresholds
|
1.2%
10/816 • Number of events 10
|
0.36%
3/828 • Number of events 3
|
|
Cardiac disorders
Erosion/Pocket Pain
|
0.49%
4/816 • Number of events 4
|
0.24%
2/828 • Number of events 2
|
|
Cardiac disorders
Hematoma
|
0.49%
4/816 • Number of events 4
|
0.85%
7/828 • Number of events 7
|
|
Cardiac disorders
Infection
|
1.2%
10/816 • Number of events 10
|
1.7%
14/828 • Number of events 15
|
|
Cardiac disorders
Lead Dislodgment/Migration
|
4.9%
40/816 • Number of events 45
|
4.2%
35/828 • Number of events 44
|
|
Cardiac disorders
Lead Fracture/Insulation Damage
|
0.37%
3/816 • Number of events 3
|
0.00%
0/828
|
|
Cardiac disorders
Oversensing/Undersensing
|
2.0%
16/816 • Number of events 18
|
0.97%
8/828 • Number of events 9
|
|
Cardiac disorders
Phrenic Nerve/Diaphragmatic Nerve Stimulation
|
1.3%
11/816 • Number of events 12
|
0.72%
6/828 • Number of events 7
|
|
Cardiac disorders
Therapy for non-ventricular rhythm
|
0.00%
0/816
|
0.36%
3/828 • Number of events 3
|
|
Cardiac disorders
Valve replacement
|
0.00%
0/816
|
0.24%
2/828 • Number of events 2
|
|
Cardiac disorders
Other cardiac
|
0.49%
4/816 • Number of events 4
|
0.36%
3/828 • Number of events 3
|
|
Endocrine disorders
Endocrine disorders
|
0.25%
2/816 • Number of events 2
|
0.00%
0/828
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.12%
1/816 • Number of events 1
|
0.00%
0/828
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.37%
3/816 • Number of events 3
|
0.60%
5/828 • Number of events 5
|
|
Nervous system disorders
CVA/TIA
|
0.25%
2/816 • Number of events 2
|
0.24%
2/828 • Number of events 2
|
|
Nervous system disorders
Neurologic other
|
0.12%
1/816 • Number of events 1
|
0.12%
1/828 • Number of events 2
|
|
Vascular disorders
DVT
|
0.37%
3/816 • Number of events 3
|
0.72%
6/828 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.25%
2/816 • Number of events 2
|
0.48%
4/828 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.37%
3/816 • Number of events 4
|
0.36%
3/828 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory other
|
0.25%
2/816 • Number of events 2
|
0.24%
2/828 • Number of events 2
|
Other adverse events
| Measure |
QuickOpt (Treatment)
n=816 participants at risk
Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
|
Control
n=828 participants at risk
Empiric programming or one-time optimization using a non-IEGM method.
|
|---|---|---|
|
Cardiac disorders
Cardiopulmonary Arrest
|
0.25%
2/816 • Number of events 2
|
0.48%
4/828 • Number of events 4
|
|
Cardiac disorders
Arrhythmias
|
8.0%
65/816 • Number of events 83
|
6.6%
55/828 • Number of events 63
|
|
Cardiac disorders
Elevated Pacing Thresholds
|
1.2%
10/816 • Number of events 13
|
0.36%
3/828 • Number of events 3
|
|
Cardiac disorders
Undersensing/Oversensing
|
1.7%
14/816 • Number of events 16
|
1.3%
11/828 • Number of events 14
|
|
Cardiac disorders
Heart Failure
|
7.5%
61/816 • Number of events 95
|
5.2%
43/828 • Number of events 63
|
|
Cardiac disorders
Hematoma
|
0.86%
7/816 • Number of events 7
|
1.6%
13/828 • Number of events 13
|
|
Cardiac disorders
Infection
|
0.49%
4/816 • Number of events 5
|
0.36%
3/828 • Number of events 3
|
|
Cardiac disorders
Lead Dislodgement/Migration
|
1.7%
14/816 • Number of events 16
|
2.1%
17/828 • Number of events 20
|
|
Cardiac disorders
MI
|
0.25%
2/816 • Number of events 2
|
0.60%
5/828 • Number of events 5
|
|
Cardiac disorders
Phrenic Nerve/Diaphragmatic Nerve Stimulation
|
4.4%
36/816 • Number of events 47
|
3.6%
30/828 • Number of events 34
|
|
Nervous system disorders
Syncope
|
0.98%
8/816 • Number of events 9
|
1.2%
10/828 • Number of events 10
|
|
Cardiac disorders
Therapy for non-ventricular rhythm
|
0.61%
5/816 • Number of events 6
|
1.9%
16/828 • Number of events 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER