Status:
WITHDRAWN
Rivet PVS Therapy in Group 2 PH-HFpEF Canada
Lead Sponsor:
NXT Biomedical
Conditions:
Heart Failure
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS thera...
Eligibility Criteria
Inclusion
- Select
- Age ≥ 18 years
- Prior diagnosis of Group 2 PH due to HFpEF, with at least one of the following resting hemodynamic criteria confirmed in the past year by right heart catheterization
- mPAP \> 20 mmHg at rest
- mPAP/CO slope \> 3 mmHg/L/min with exercise
- Confirmation of the following hemodynamic criteria during supine exercise: PCWP ≥ 25 mmHg, or PCWP/CO slope \> 2 mmHg/L/min
- Chronic symptomatic heart failure documented by the following:
- NYHA HF Class II with history \> II, or Class III, or ambulatory Class IV
- ≥ 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 cardiologist according to current ACCF/AHA guidelines that is expected to be maintained without change for 1 month (excluding diuretic dosage changes for HF optimization within 30 days of the Index Procedure)
- 6MWD ≥ 100 m
- Select
Exclusion
- Any therapeutic intracardiac intervention within the last 30 days
- PH Group 1, 3, 4 or 5
- Mean RAP \>16 mmHg by RHC at rest on room air
- Right ventricular dysfunction, defined as one or more of the following
- Greater than moderate RV dysfunction as assessed by TTE and/or MRI
- RV FAC \< 35%
- TAPSE \< 14 mm via TTE
- 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
- Left ventricular ejection fraction \< 50%
- Severe heart failure, defined as one or more of the following:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- If BMI \< 30, Cardiac Index \< 2.0 L/min/m2
- If BMI ≥ 30, Cardiac Index \< 1.8 L/min/m2
- Requires continuous intravenous inotropic infusion
- Requires mechanical circulatory support
- Currently on the cardiac transplant waiting list
- Chronic renal dysfunction defined as: eGFR \< 35 mL/min/1.73 m2 by the CKD-Epi equation
- Chronic pulmonary disease defined as one or more of the following:
- Requires continuous home oxygen therapy
- Recent hospitalization for exacerbation within 12 months prior to screening
- FEV1 \< 50% predicted
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05332873
Start Date
October 1 2023
End Date
May 1 2025
Last Update
June 3 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7