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After RHC and sensor implantation, all patients had follow-up study visits at 1 month, 3 months, 6 months, and every 6 months
thereafter until study termination.
Study Endpoints
The primary and secondary endpoints were evaluated after 6 months of patient follow-up. The primary safety endpoints were
1) Freedom from device / system-related complications (DSRC), and 2) Freedom from pressure sensor failures. The primary efficacy
endpoint was the rate of HF hospitalizations. All hospitalizations were adjudicated by an independent Clinical Events Committee
(CEC) who were blinded to treatment assignment. Secondary endpoints were tested in a hierarchical fashion and included changes
in PA pressures, proportion of subjects hospitalized for HF, days alive outside of the hospital for HF, and quality of life. Because
blinded follow-up continued until the last patient completed 6 months of follow-up, the average patient follow-up was much longer
(17.6 months) and pre-specified supplementary analyses were conducted on the full duration of follow-up data (Randomized
Access).
Patient Demographics and Disposition
575 patients were consented for trial enrollment and underwent right heart catheterization (RHC). Of these 575 patients, 25 (4.3%)
underwent a RHC but did not receive an implant primarily because of anatomical/physiological conditions identified during the RHC.
Of the 550 randomized patients, 270 were assigned to the Treatment group and 280 to the Control group. The two groups were
similar with respect to baseline characteristics (see table below).
Table 2. Patient Demographics
Randomized Group

Treatment Control
2
Variables (N=270) (N=280) p-value
Age (years) 61.3 ± 12.98 (270) 61.8 ± 12.73 (280) 0.5927
Male 194/270 (71.9%) 205/280 (73.2%) 0.7745
Race (White) 196/270 (72.6%) 205/280 (73.2%) 0.9236
Systolic BP (mmHg) 121.2 ± 22.52 (270) 123.2 ± 21.01 (280) 0.1286
Heart Rate (bpm) 72.4 ± 12.91 (269) 73.0 ± 12.14 (280) 0.4873
BMI 30.5 ± 6.50 (270) 30.9 ± 7.35 (280) 0.6228
BUN (mg/dL) 29.6 ± 17.99 (248) 28.1 ± 16.17 (267) 0.6325
Creatinine (mg/dL) 1.4 ± 0.47 (270) 1.4 ± 0.42 (280) 0.5560
GFR (mL/min/1.73m²) 60.4 ± 22.50 (270) 61.8 ± 23.20 (280) 0.5638
Ejection Fraction (EF>=40%) 62/270 (23.0%) 57/279 (20.4%) 0.5343
Cardiac Output (L/min) 4.5 ± 1.41 (270) 4.6 ± 1.54 (278) 0.5499
Cardiac Index (L/min/m²) 2.1 ± 0.59 (270) 2.2 ± 0.64 (278) 0.4405
PVR 2.9 ± 2.02 (270) 2.7 ± 1.82 (278) 0.4609
PA Wedge Pressure (mmHg) 17.5 ± 7.97 (270) 19.0 ± 8.12 (280) 0.0276
PA Mean Pressure (mmHg) 28.9 ± 9.92 (270) 29.9 ± 10.05 (280) 0.3021
CRT-D/ICD Implant 179/270 (66.3%) 197/280 (70.4%) 0.3145
Ischemic Cardiomyopathy 158/270 (58.5%) 174/280 (62.1%) 0.4327
Hypertension 207/270 (76.7%) 220/280 (78.6%) 0.6100
Hyperlipidemia 204/270 (75.6%) 218/280 (77.9%) 0.5458
Coronary Artery Disease 182/270 (67.4%) 202/280 (72.1%) 0.2290
History of MI 134/270 (49.6%) 137/280 (48.9%) 0.9320
Diabetes Mellitus 130/270 (48.1%) 139/280 (49.6%) 0.7337
AFIB 120/270 (44.4%) 135/280 (48.2%) 0.3932
COPD 76/270 (28.1%) 83/280 (29.6%) 0.7078
ACE/ARB use 205/270 (75.9%) 222/280 (79.3%) 0.3584
Beta Blocker use 243/270 (90.0%) 256/280 (91.4%) 0.6595

The mean follow-up during Randomized Access was 17.6 months for a total duration of approximately 800 patient years. During the
course of Randomized Access, 93 patients in the Treatment group and 110 patients in the Control group exited the study with the
primary reason being death.
A total of 347 patients (177 in the Treatment group and 170 in the Control group) completed Randomized Access and entered Open
Access. The mean follow-up during Open Access was 13 months for a total duration of approximately 400 patient years. During the
course of Open Access, 58 patients in the Treatment group and 43 patients in the Control group exited the study with the primary
reason being death.

2 Wilcoxon Rank-Sum Test for continuous measures and Fisher's exact test for categorical measures.

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