Rivet PVS Therapy in Group 2 PH-HFpEF Canada

NCT05332873 | Withdrawn DMC FDA Device

• 1 other identifier: CIP-A-21-0001-CAN
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Rate of Major Adverse Events

  Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at implantation procedure (Day 0) and up to 1-month post-procedure (Day 30)

  1 month

• Rate of Technical Success of the Rivet Shunt Implantation Procedure

  Study device is implanted as intended and confirmation of a patent pulmonary-to-venous shunt between the RPA and SVC by qualitative assessment via angiography and/or echocardiography at implantation procedure.

  At time of procedure

Secondary Outcomes (4)

• Adverse Events through 12 months

  12 months

• Change in Hemodynamics at 12 months - PCWP

  12 Months

• Change in Kansas City Cardiomyopathy Questionnaire

  12 months

• Change in RV Chamber Size at 12 months - Diameter

  12 months

Study Arms (1)

Rivet Shunt Therapy

EXPERIMENTAL

Device: Rivet Shunt

Interventions

Rivet Shunt DEVICE

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

Rivet Shunt Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• MWD ≥ 100 m

You may not qualify if:

• 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

Sponsors & Collaborators

• NXT Biomedical: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)