Clinical trial NCT05205265: Rivet PVS Therapy in Group 2 PH-HFpEF
Official title: Safety and Efficacy of the Rivet Pulmonary-to-Venous Shunt (PVS) Therapy in Patients With Group 2 Pulmonary Hypertension (PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Pulmonary Hypertension
Lead sponsor: NXT Biomedical
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 therapy in patients with symptomatic pulmonary hypertension.


Eligibility criteria: Select Inclusion Criteria:

* 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

Select Exclusion Criteria:

* 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
  2. If BMI \< 30, Cardiac Index \< 2.0 L/min/m2
  3. If BMI ≥ 30, Cardiac Index \< 1.8 L/min/m2
  4. Requires continuous intravenous inotropic infusion
  5. Requires mechanical circulatory support
  6. Currently on the cardiac transplant waiting list
* Chronic renal dysfunction defined as one or more of the following:

  1. Currently requiring dialysis; OR
  2. eGFR \< 35 mL/min/1.73 m2 by the CKD-Epi equation
* Chronic pulmonary disease defined as one or more of the following:

  1. Requires continuous home oxygen therapy
  2. Recent hospitalization for exacerbation within 12 months prior to screening
  3. FEV1 \< 50% predicted

Primary outcomes:
measure: Rate of Major Adverse Events
timeFrame: 1 month
measure: Rate of Technical Success of the Rivet Shunt Implantation Procedure
timeFrame: At time of procedure
Secondary outcomes:
measure: Adverse Events through 12 months
timeFrame: 12 months
measure: Change in Hemodynamics at 12 months - PCWP
timeFrame: 12 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 months
measure: Change in RV Chamber Size at 12 months - Diameter
timeFrame: 12 months
measure: Change in Hemodynamics at 12 months - mPAP/CO Slope
timeFrame: 12 months
measure: Change in RV function at 12 months - RV Fractional Area Change (FAC)
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charlottesville
country: United States
facility: UVA Cardiology Research
state: Virginia
Study officials:
References: