|
| | FIX-HF-5 Pilot
[12] | FIX-CHF-4
[13]
(Group 1/Group 2) | FIX-HF-5
[20] | FIX-HF-5C
[21] |
|
| Year | 2006 | 2008 | 2011 | 2018 |
|
| Sample Size (N) | 49 | 164 | 428 | 160 |
|
| Patients Withdrawn | 0 | 5 (group 1)
4 (group 2) | 17 (OMT)
6 (CCM) | 3 (OMT)
1 (CCM) |
|
| Study Design | CCM to all patients, 25 active CCM vs 24 inactive CCM | Crossover Study: CCM to all patients; Group 1 (N=80; CCM first 3 months), Group 2 (N=84; sham first 3 months) | CCM Implant (N = 215) vs OMT (N=213) | CCM Implant (N = 74) vs OMT (N = 86) |
|
| Ejection Fraction Inclusion Criteria | < 35% | < 35% | ≤ 35% | ≥25% and ≤ 45% |
|
| Mean Follow up | 6 months | 6 months | 6 months (noninferiority at 12 months) | 6 months |
|
| Outcomes | NYHA Class, 6MWD, Stress Test, Holter Monitoring | Holter Monitoring.
Changes in peak VO2, MLHFQ, and 6MWD at the end of 12 and 24 weeks. | Ventilatory anaerobic threshold, peak O2, MLHFQ, non-inferiority based on mortality and hospitalization with 12.5% allowable delta (12 months) | Peak VO2, MLWHFQ, NYHA Class, 6MWD, safety assessed by percentages of patients free of device-related events. |
|
| Study Centers | Single Center – Lone Star Arrhythmia and Heart Failure Center - Texas | Single Center - Germany | 50 US Centers
| 42 Centers (US, Germany, and Czechia). |
|
| Mean age (CCM/OMT) | 52 ± 15.0
59.6 ± 12.0 | 58.9 ± 9.8
59.9 ± 10 | 58.09 ± 12.79
58.55 ± 12.33 | 63 ± 11
63 ± 11 |
|
| Male (CCM/OMT) | 68%/71% | 88.8%/81% | 73.5%/70.9% | 73%/79.1% |
|
| SBP (mmHg) (CCM/OMT) | 118.6 ± 19.7
115 ± 20.6 | 114.7 ± 17.0
117.1± 17.9 | 116.65 ± 19.48
115.61 ± 17.61 | 123 ± 18
126 ± 19 |
|
| QRS Duration (msec) (CCM/OMT) | 109.2 ± 15.8
101.3 ± 14.2 | 119.9 ± 28.3
116.3 ± 26.6 | 101.63 ± 15.30
101.51 ± 12.81 | 103 ± 13.0
103.6 ± 12.1 |
|
| ICD/Pacemaker (CCM/OMT) | 88% (22)
83% (20) | 68.3% (55)
59.4% (50) | 96% (207/215)
95% (202/213) | 87.8% (65/74)
84.9% (73/86) |
|
| 6MWD Baseline (m) (CCM/OMT) | 321
352 ± 95.4 | 386 ± 103
394 ± 102 | 326.38 ± 82.10
323.99 ± 92.44 | 317 ± 88
324 ± 90 |
|
| NYHA Class Included | III and IV | II and III | III and IV | III and IV |
|
| NYHA Class III (CCM/OMT) | 100%
96% | 72.5%
80% | 91.16%
85.92% | 86.5%
90.7% |
|
| Ischemic Cardiomyopathy (CCM/OMT) | 64%
67% | 63.8%
56% | 64.7%
66.7% | 62.2%
59.3% |
|
| Baseline LVEF () (CCM/OMT) | 24.9 ± 6.5
31.4 ± 7.4 | 29.3 ± 6.6
29.8 ± 7.8 | 25.74 ± 6.60
26.09 ± 6.54 | 33 ± 6
33 ± 5 |
|
| Ventilatory Anaerobic Threshold (VAT) (CCM/OMT) | 10.6 ± 2.4
12.3 ± 2.5 | Not documented | 10.95 ± 2.24
10.97 ± 2.18 | Not documented |
|
| Peak O2 Consumption (CCM/OMT) | 14.3 ± 2.8
16.0 ± 2.9 | 14.1 ± 3.0
13.6 ± 2.7 | 14.74 ± 3.06
14.71 ± 2.92 | 15.5 ± 2.6
15.4 ± 2.8 |
|
