Clinical Trials

Rivet PVS Therapy in Group 2 PH-HFpEF Canada

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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Inclusion Criteria:

- 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.

1. mPAP > 20 mmHg at rest. 2. 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: 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 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.

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Exclusion Criteria:

- 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.

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.

- 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: 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05332873
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NXT Biomedical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Heart Failure, Pulmonary Hypertension

Arms & Interventions

Arms

Experimental: Rivet Shunt Therapy

Interventions

Device: - Rivet Shunt

The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.