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Transcatheter Shunt System
Transcatheter Shunt System for Heart Failure (ALT-FLOW II Trial)
N/A
Recruiting
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and NYHA class II to ambulatory NYHA class IV (IVa)
Symptomatic heart failure
Must not have
Severe heart failure defined as one or more of the below: ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF
Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Summary
This trial studies if a medical device is effective in treating a medical condition.
Who is the study for?
This trial is for adults with heart failure who have been on stable heart medication for over a month, experienced at least one hospitalization due to heart failure in the past year, and show specific signs of lung congestion during exercise. They must not have severe kidney issues, recent strokes or infections, certain types of valve disease, very poor walking ability or extremely severe heart failure.
What is being tested?
The ALT-FLOW II Trial is testing the Edwards APTURE transcatheter shunt system against a sham procedure (a fake operation that seems real) to see if it helps patients with heart failure. Participants are randomly chosen to receive either the actual device implantation or a pretend procedure without receiving the device.
What are the potential side effects?
Potential side effects from the Edwards APTURE system could include bleeding, infection at the site of insertion, irregular heartbeat, blood clots leading to stroke or other complications related to having a foreign body placed inside the heart.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is reduced but not severely, and I have moderate to severe difficulty with physical activity.
Select...
I have heart failure that causes me symptoms.
Select...
I have been hospitalized for heart failure or have high BNP/NT-proBNP levels.
Select...
My heart test shows high lung pressure during exercise.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure and cannot move around easily.
Select...
I have not had a stroke, TIA, DVT, or pulmonary embolus in the last 6 months.
Select...
My heart's right side is not working well, or I have signs of liver issues due to heart problems, or my BMI is 45 or more.
Select...
My kidney function is low, shown by high creatinine or low eGFR, or I am on dialysis.
Select...
I have moderate to severe heart valve disease.
Select...
I can walk less than 50 meters or more than 450 meters in six minutes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device + Medical Therapy: Subjects with Early Major Adverse Events
Mean change in PCWP from baseline at 20W exercise
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APTURE shunt + medical therapyExperimental Treatment1 Intervention
Group II: Sham + medical therapyPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
63,008 Total Patients Enrolled
14 Trials studying Heart Failure
3,137 Patients Enrolled for Heart Failure