Atrial Shunt for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Ottawa Heart Institute, Ottawa, Canada
Heart Failure
Atrial Shunt - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new device can be used to treat heart failure.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Heart Failure

Study Objectives

This trial is evaluating whether Atrial Shunt will improve 1 primary outcome and 4 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of Day 0.

10 Days post-op
Procedural Success
30 Days
Clinical Success
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Month 6
Performance/Effectiveness
Day 0
Device Success

Trial Safety

Safety Progress

1 of 3

Other trials for Heart Failure

Trial Design

1 Treatment Group

Edwards Transcatheter Atrial Shunt System
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Atrial 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.

Edwards Transcatheter Atrial Shunt System
Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 3 months, 6 months for reporting.

Closest Location

University of Ottawa Heart Institute - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed and dated approved informed consent form prior to study related procedures
Eighteen years of age or older
NYHA class II with a history of NYHA class III or greater; NYHA class III, OR ambulatory NYHA class IV within last 12 months
≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); OR treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry
In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA Guidelines and that is expected to be maintained without change for 3 months
Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercise stress test as measured at end-expiration
Willing to attend study follow-up assessments for up to 3 years

Patient Q&A Section

What is heart failure?

"Heart failure is the reduced heart's ability to meet the body's natural needs for oxygen and nutrients. Symptoms include shortness of breath, light headedness, dizziness, and in severe or sudden-switching spells, fainting. The signs and symptoms can change as the heart is unable to work as optimally as it used to. It's in heart failure that you’ll find increased blood pressure, swelling in the legs, nausea, vomiting, and chest pain. Also, this is where swelling, the enlarging of the spleen and/or liver occur. If left untreated heart failure can cause damage to the heart muscle and heart failure can cause damage to vital organs like the lungs. Heart failure is a chronic progressive disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart failure?

"Most persons who are hospitalized for heart failure have heart failure exacerbation. Many inpatient care for HF will be associated with inpatient heart failure and is a significant source of hospital costs that could be eliminated or significantly reduced if cardiac rehabilitation is integrated into heart failure care. Thus, programs should encourage cardiac rehabilitation of heart failure patients in a pre-discharge setting, particularly outpatient rehabilitation." - Anonymous Online Contributor

Unverified Answer

What causes heart failure?

"Causes of HF vary, with age being a major determinant. Often the disease has gone undetected for many years. People who present with advanced HF are more likely to be younger and healthier. The treatment goal is to slow progressive deterioration of cardiac function. These patients need to be followed up closely, as they have a relatively poor prognosis." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart failure?

"Signs include fatigue, orthopnea, fatigue, and loss of appetite. The latter three are not necessarily associated with congestion, and are not typically found in a patient admitted to ICU for CHF." - Anonymous Online Contributor

Unverified Answer

Can heart failure be cured?

"There is no current evidence that a cure can be effected with either drug treatment or cardiac [transplant](https://www.withpower.com/clinical-trials/transplant)ation for patients with congestive heart failure. The primary treatments for HF are medical and are supportive rather than curative and are only used until transplantation can be planned. It has been demonstrated both by large retrospective studies as well as in the recent HOPE trial that a good prognosis may be achieved if patients survive a year beyond date of diagnosis of congestive heart failure." - Anonymous Online Contributor

Unverified Answer

How many people get heart failure a year in the United States?

"around half of people receive treatment for heart failure from a cardiologist. The American Heart Association recommends against using restrictive clinical criteria in the diagnosis of heart failure without the use of an echocardiogram." - Anonymous Online Contributor

Unverified Answer

Is atrial shunt typically used in combination with any other treatments?

"The presence of an atrial shunt significantly increased the risk of a failed attempt at cardiac resynchronization therapy but not of cardiac arrest or overall survival." - Anonymous Online Contributor

Unverified Answer

How serious can heart failure be?

"This is the first study to demonstrate the ability of echocardiography to predict all-cause mortality in CHF patients. If all-cause mortality for a group is ascertained accurately by echocardiography and validated in patients who were subsequently enrolled in studies of clinical management of CHF, then the need to exclude patients with CHF from clinical trials will be dramatically reduced." - Anonymous Online Contributor

Unverified Answer

What does atrial shunt usually treat?

"Patients with atrial shunts typically present with a restrictive pulmonary pattern on ventilation/perfusion scan, while patients with P-ASB may also have restrictive lesions on the HRCTs. Atrial shunts alone are useful as a therapeutic option in patients with severe left ventricular failure. Patients with severe atrial shunts should be treated in a high dependency unit to prevent recurrent atrial asystole and stroke." - Anonymous Online Contributor

Unverified Answer

Is atrial shunt safe for people?

"Moderate amounts of left atrial shunting does not seem a hazard. Findings from a recent study also highlights that the impact of atrial shunting on LV filling is likely to be small and that this would not be easily detectable on routine diagnostic imaging. We should be cautious of using a trans-esophageal echocardiogram to detect atrial shunting in people with HF, and do not think it is worthwhile to perform this additional investigation. We therefore conclude that left atrial shunting is safe in those with HF." - Anonymous Online Contributor

Unverified Answer

Has atrial shunt proven to be more effective than a placebo?

"The administration of left atrial shunts provided significant advantages compared with a placebo. These benefits did not vary, independent of age, gender, baseline disease state, treatment duration, and atrial size." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for heart failure?

"Physicians' recommendations, based on patient demographics and patient characteristics, on the inclusion and exclusion criteria for clinical trials for heart failure remain inconsistent. Findings from a recent study strongly support the concept of establishing clinical guidelines on inclusion/exclusion criteria for heart failure randomized trials." - Anonymous Online Contributor

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