Rivet PVS Therapy in Group 2C

Overview

About this study

The purpose of this study is to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/m^2.

3. If BMI ≥ 30, Cardiac Index < 1.8 L/min/m^2.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Trevor Simard, M.D., Ph.D.

Open for enrollment

Contact information:

Trevor Simard M.D., Ph.D.

(507) 284-6945

Simard.Trevor@mayo.edu

More information

Publications

Publications are currently not available