Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NXT Biomedical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years
Prior diagnosis of Group 2 PH due to HFpEF, with the following resting hemodynamic criteria confirmed in the past year by right heart catheterization
a. mPAP ≥ 25 mmHg at rest or mPAP/CO slope \> 3 mmHg/L/min during incremental exercise
Confirmation of the following hemodynamic criteria during supine exercise
a. PCWP ≥ 25 mmHg, or PCWP/CO slope \> 2 mmHg/L/min
Chronic symptomatic heart failure documented by the following:
1. NYHA HF Class II with history \> II, or Class III, or ambulatory Class IV
2. ≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value \> 400 pg/mL in normal sinus rhythm or \> 750 pg/mL in atrial fibrillation in past 6 months
Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating HF physician according to current ACCF/AHA guidelines that is expected to be maintained without change for 6 months (excluding diuretic dosage changes for HF optimization within 90 days of the Index Procedure)
6MWD ≥ 150 m
You may not be if
Any therapeutic intracardiac intervention within the last 30 days
PH Group 1, 3, 4 or 5
Mean RAP \>12 mmHg by RHC at rest on room air
Right ventricular dysfunction, defined as one or more of the following
1. Greater than moderate RV dysfunction as assessed by TTE and/or MRI
2. RV FAC \< 35%
3. TAPSE \< 14 mm via TTE
4. RV size severely enlarged compared to LV size as estimated by TTE and/or MRI
Severe tricuspid valve regurgitation
Peak systolic pulmonary arterial pressure \> 80 mmHg by RHC at rest while awake
Mean pulmonary arterial pressure \> 50 mmHg by RHC at rest while awake
PVR \> 6 Wood units at rest while awake on room air or exercise PVR \> 2 Wood Units
Left ventricular ejection fraction \< 50%
Severe heart failure, defined as one or more of the following:
1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
