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Heart FailureNCT05205265

Rivet PVS Therapy in Group 2 PH-HFpEF

A study testing Rivet Shunt in people with Heart Failure and Pulmonary Hypertension, run by NXT Biomedical at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Pulmonary Hypertension
What is being tested?
Rivet Shunt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
10 May 2022to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  1. 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
  1. 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UVA Cardiology Research

    Charlottesville, Virginia, 22908

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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)

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.

Being tested
Rivet Shunt
Medical subject headings
Heart Failure, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivet ShuntDevice

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

Study groups in NCT05205265
Study groupRoleWhat they receive
Rivet Shunt TherapyExperimentalNot described
Receives: Device: Rivet Shunt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 month

  2. 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.

    Measured: At time of procedure

Secondary outcomes (6)

  1. Adverse Events through 12 months

    Composite of MACCRE and re-intervention for study device related complications (as described above), progression of PH and/or HF disease, and all-cause mortality to 12 months post-procedure

    Measured: 12 months

  2. Change in Hemodynamics at 12 months - PCWP

    Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline

    Measured: 12 Months

  3. Change in Kansas City Cardiomyopathy Questionnaire

    Change in KCCQ score between baseline and 12 months.

    Measured: 12 months

  4. Change in RV Chamber Size at 12 months - Diameter

    Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months

    Measured: 12 months

  5. Change in Hemodynamics at 12 months - mPAP/CO Slope

    Change in exercise mPAP/CO Slope (mean pulmonary artery pressure/cardiac output slope) from baseline

    Measured: 12 months

  6. Change in RV function at 12 months - RV Fractional Area Change (FAC)

    Change in RV FAC assessed by a core lab between baseline and 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start10 May 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Why it stopped: Commercial decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205265
Sponsor's protocol ID
CIP-A-21-0001
Status last verified
May 2024
First submitted
17 Nov 2021
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rivet Shunt in people with Heart Failure and Pulmonary Hypertension, run by NXT Biomedical at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Major Adverse Events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05205265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.

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