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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months

Awards & highlights

ALT-FLOW II Trial 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.Check my eligibility

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.See study design

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.

ALT-FLOW II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is reduced but not severely, and I have moderate to severe difficulty with physical activity.

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I have heart failure that causes me symptoms.

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I have been hospitalized for heart failure or have high BNP/NT-proBNP levels.

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My heart test shows high lung pressure during exercise.

ALT-FLOW II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Device + Medical Therapy: Subjects with Early Major Adverse Events

Mean change in PCWP from baseline at 20W exercise

Secondary outcome measures

6MWT change from baseline at 6-month follow-up

KCCQ-OSS change from baseline at 6-month follow-up

Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (≥) a 15-point improvement from baseline KCCQ-OSS or at least (≥) a 25m improvement from baseline 6MWT.

ALT-FLOW II Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: APTURE shunt + medical therapyExperimental Treatment1 Intervention

Group II: Sham + medical therapyPlacebo Group1 Intervention

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,474 Total Patients Enrolled

14 Trials studying Heart Failure

3,161 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.

Are there any openings for participation in this experiment currently?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently recruiting participants, with the original posting on April 1st 2023 and last update occurring on September 5th of the same year. 100 people must be recruited from one site for completion of the study."

Answered by AI

How many participants are eligible to partake in this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this investigation is actively enrolling participants, with the first posting on April 1st 2023 and latest update being September 5th 2021. The trial has a target of 100 patients from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

2023. "ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05686317.