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Device

Transcatheter Atrial Shunt for Heart Failure (ALt FLOW US 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
Chronic symptomatic Heart Failure (HF) documented by specific criteria
Successful reversibility of PH under a resting Sodium Nitroprusside* challenge (if baseline PVR is > 4.0, for Cohort B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

ALt FLOW US Trial Summary

This trial will test a new device to treat heart failure. The device will be inserted in the heart to help it pump better.

Who is the study for?
This trial is for adults over 18 with chronic heart failure who are on stable heart medication and can attend follow-ups for up to 5 years. It's not for those with severe heart issues, valve diseases, certain cardiomyopathies, renal insufficiency, metal allergies, or life expectancy less than a year due to non-heart conditions.Check my eligibility
What is being tested?
The study tests the Edwards Transcatheter Atrial Shunt System's safety and effectiveness in patients with heart failure. The device aims to relieve symptoms by creating a small passage between the left and right atria of the heart.See study design
What are the potential side effects?
Potential side effects may include discomfort at the insertion site, irregular heartbeat, bleeding or blood clots around the device area. There might also be risks associated with catheter-based procedures like infection.

ALt FLOW US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic heart failure.
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My pulmonary hypertension improved with a specific test.
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I am on a stable treatment plan for heart failure.
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I am 18 years old or older.

ALt FLOW US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Secondary outcome measures
Clinical Success
Device Success
Performance/Effectiveness
+1 more

ALt FLOW US Trial Design

1Treatment groups
Experimental Treatment
Group I: Edwards Transcatheter Atrial Shunt SystemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
179 Previous Clinical Trials
60,971 Total Patients Enrolled
13 Trials studying Heart Failure
3,086 Patients Enrolled for Heart Failure

Media Library

Edwards Transcatheter Atrial Shunt System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03523416 — N/A
Heart Failure Research Study Groups: Edwards Transcatheter Atrial Shunt System
Heart Failure Clinical Trial 2023: Edwards Transcatheter Atrial Shunt System Highlights & Side Effects. Trial Name: NCT03523416 — N/A
Edwards Transcatheter Atrial Shunt System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03523416 — N/A

Frequently Asked Questions

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

How many individuals have volunteered to partake in this research?

"That is correct. The clinicaltrials.gov website lists this medical study as actively recruiting participants since its initial posting on July 31st, 2018 and most recently being updated in January 25th 2022. A total of 55 patients must be enrolled across 11 different sites."

Answered by AI

Are enrollment slots still available for this medical experiment?

"Data on clinicaltrials.gov suggests that this medical trial is actively recruiting volunteers, with its first posting occurring on July 31st 2018 and most recent revision made January 25th 2022."

Answered by AI

How many healthcare facilities are hosting this investigation?

"This clinical trial is being conducted at Montefiore Medical Center (Bronx, NY), UC San Diego Health (La Jolla, CA) and University of Kansas (Kansas City, KS). Additionally 11 other sites are participating."

Answered by AI
~8 spots leftby Dec 2024