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Atrial Shunt

Atrial Shunt for Heart Failure

N/A
Waitlist Available
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Study Summary

This trial is testing a new device to help people with heart failure. The device is placed in the heart and helps to redirect blood flow. The trial will evaluate the safety and effectiveness of the device.

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, 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

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
180 Previous Clinical Trials
61,524 Total Patients Enrolled
14 Trials studying Heart Failure
3,211 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

How many participants are authorized to partake in this trial?

"Affirmative. As detailed on clinicaltrials.gov, this medical trial is open for enrollment and was initially posted on the first of January 2019 before being updated lastly on July 21st 2020. 50 participants need to be found from two distinct sites in order to complete the research agenda."

Answered by AI

Is this research project currently open to new participants?

"Affirmative, the information present on clinicaltrials.gov displays that this project is still seeking participants. It was initially posted on January 1st 2019 and has been updated as recently as July 21 2020. This trial requires a total of 50 persons to be recruited from two sites."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~8 spots leftby Apr 2025