V-Wave Interatrial Shunt for Pulmonary Arterial Hypertension

1
Effectiveness
1
Safety
Keck Medical Center of USC, Los Angeles, CA
Pulmonary Arterial Hypertension+2 More
V-Wave Interatrial Shunt - Device
Eligibility
18+
All Sexes
Eligible conditions
Pulmonary Arterial Hypertension

Study Summary

This study is evaluating whether a new device may help treat pulmonary arterial hypertension.

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Eligible Conditions

  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension, Primary, 1
  • Hypertension
  • Familial Primary Pulmonary Hypertension

Treatment Effectiveness

Study Objectives

This trial is evaluating whether V-Wave Interatrial Shunt will improve 4 primary outcomes and 4 secondary outcomes in patients with Pulmonary Arterial Hypertension. Measurement will happen over the course of 3 months.

1 and 12 months
Freedom from device related MACNE at 1 and 12 months after implantation
12 months
Improvement in Exercise Capacity between baseline and 12 months
Improvement in Quality of Life between baseline and 12 months
Improvement in WHO Functional Class between baseline and 12 months
3 months
Device Success-Percentage of patients implanted with right to left interatrial flow
Procedure Success-Percentage of patients successfully implanted with study device
Safety-Percentage of Treatment patients experiencing any major adverse event
Safety-Percentage of Treatment patients experiencing major device-related adverse events

Trial Safety

Trial Design

2 Treatment Groups

Control
Therapy: V-Wave Shunt

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. V-Wave Interatrial Shunt is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Therapy: V-Wave Shunt
Device
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 and 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 and 12 months for reporting.

Closest Location

Keck Medical Center of USC - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.
Main

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can pulmonary arterial hypertension be cured?

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At the time of this writing, optimal clinical care for patients with pulmonary arterial hypertension is limited. However, treatments are being developed and are under investigation. At this stage, there is no validated way to predict which patients will or will not respond.

Unverified Answer

What are common treatments for pulmonary arterial hypertension?

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Antihypertensive agents for PAH are commonly used in the form of beta-adrenergic agonists, including salbutamol, or calcium channel blockers, including diltiazem. If patients respond poorly to vasodilators, other treatment options are available. Pulmonary thromboendarterectomy can be used to treat some individuals with PAH but is not curative. Hemopressin can be used for severe disease and lung transplantation may be an option.

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What are the signs of pulmonary arterial hypertension?

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PAP>60 mm Hg is one of the most frequent criteria for making a definitive diagnosis of PAH. However, it is difficult to distinguish PAH from other forms of PHT (e.g. COPD) using PAP and may require two separate measurements.

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How many people get pulmonary arterial hypertension a year in the United States?

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Around 5,000 people with PAH will die each year in the United States. PAH has a profound impact on disability and quality of life with a cost to the United States estimated at $10 billion.

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What causes pulmonary arterial hypertension?

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PAH may occur as a consequence of many conditions, both acquired and developmental. All pulmonary arteries arise from the common pulmonary trunk and this makes PAH a systemic disease with multifactorial aetiology.

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What is pulmonary arterial hypertension?

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When severe, idiopathic PAH can develop into heart failure and death in the course of many years. Most patients have [pulmonary hypertension](https://www.withpower.com/clinical-trials/pulmonary-hypertension) only at the time of diagnosis. Pulmonary hypertension is a disorder of blood circulation, the abnormal retention of blood in lungs, where blood flow is less efficient in the lungs and the heart. In patients with pulmonary arterial hypertension, the left ventricle of the heart cannot get enough blood from the circulation. This is due to the inability of the left side of the heart to work well. This compromises its ability to pump a sufficient amount of blood to the rest of the body. The disorder affects the right side of the heart, too, but to a much lesser degree.

Unverified Answer

Who should consider clinical trials for pulmonary arterial hypertension?

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Findings from a recent study indicate that patients may want to initiate pulmonary arterial hypertension drug treatment if they are interested in clinical research (for example, in response to new research findings), are stable on PAH-targeted therapy, and will be capable of participating in the research and submitting informed consent for new PAH therapies. Patients who would not qualify for clinical investigation can continue to use medical treatment and obtain benefit from drug therapy for the remainder of their disease course under the oversight of their doctors.

Unverified Answer

Is v-wave interatrial shunt safe for people?

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At higher than 2 mA, IAS may not affect right ventricular function, as it can generate positive pressure and reduce pulmonary pressure. However, the low incidence of ventricular dyssynchrony associated with the lower pacing thresholds may minimize the clinical impact of IAS. © 2015 Wiley Periodicals, Inc.

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What is v-wave interatrial shunt?

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We conclude that V-wave interatrial shunting through an intact right superior pulmonary vein to the right atrium exists in normal subjects. V-wave interatrial shunting is present in patients with pulmonary arterial hypertension (PAH). The significance of this finding remains elusive. We propose that this shunting is a manifestation of left-to-right shunting in patients with PAH. It may account for the reversal of the normal shunt direction seen on Doppler-echocardiography in patients with PAH.

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Is v-wave interatrial shunt typically used in combination with any other treatments?

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According to current data, V-wave interatrial shunting is rarely used as the sole diagnostic and interventional treatment for PH, and its combination with any of the other medications is hardly indicated in clinical practice. In general, this technique should be used judiciously especially when treating PH patients on a long-term basis.

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What is the average age someone gets pulmonary arterial hypertension?

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The majority of patients (77%) were less than 45 years of age and 5% were 55 years or older. Male gender, a history of smoking cigarettes, a history of COPD, and congestive cardiac failure may help predict long-term mortality.

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Does v-wave interatrial shunt improve quality of life for those with pulmonary arterial hypertension?

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In the majority of those with PAH, V-wave IAS did not significantly affect the QoL in this prospective, multicenter study. However, the use of these devices for a significant number of patients with PAH was associated with a clinically significant improvement in QoL.

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See if you qualify for this trial
Get access to this novel treatment for Pulmonary Arterial Hypertension by sharing your contact details with the study coordinator.