WithdrawnNot Applicable

Rivet PVS Therapy in Group 2 PH-HFpEF

Stopped: Commercial decision

United States0Started 2022-05-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. 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

What they're measuring

Rate of Major Adverse Events

Timeframe: 1 month

Rate of Technical Success of the Rivet Shunt Implantation Procedure

Timeframe: At time of procedure

Trial details

NCT IDNCT05205265

SponsorNXT Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

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