ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)

NCT04965623 | Withdrawn DMC FDA Device

• 1 other identifier: 2018-14
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Rate of Safety Events (MACCREE, Re-Intervention)

  Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.

  30 Days

Secondary Outcomes (4)

• Rate of Device Success

  Day 0

• Rate of Procedural Success

  10 Days post-op

• Change in Qp/Qs

  Baseline, 3 months, 6 months

• Change in PCWP

  Baseline, 3 months, 6 months

Study Arms (1)

Edwards Transcatheter Atrial Shunt System

EXPERIMENTAL

Edwards Transcatheter Atrial Shunt System

Device: Atrial Shunt

Interventions

Atrial Shunt DEVICE

Transcatheter treatment of symptomatic left heart failure patients

Edwards Transcatheter Atrial Shunt System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
• ≥ 18 years old
• Chronic symptomatic Heart Failure (HF) documented by the following:
• NYHA class III or ambulatory NYHA class IV within last 12 months AND
• ≥ 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; OR an NT-pro BNP value \> 150 pg./ml in normal sinus rhythm, \> 450 pg./ml in atrial fibrillation, or a BNP value \> 50 pg./ml in normal sinus rhythm, \> 150 pg./ml in atrial fibrillation within the past 6 months.
• 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/ESC 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 5 years

You may not qualify if:

• Severe heart failure defined as one or more of the below:
• ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
• If BMI \< 30, Cardiac index \< 2.0 L/min/m2
• If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
• Inotropic infusion (continuous or intermittent) within the past 6 months
• Patient is on the cardiac transplant waiting list
• LVEF \< 20%
• Presence of significant valve disease defined by the site cardiologist as:
• Mitral valve regurgitation defined as grade \> 3+ MR or \> moderate MS
• Tricuspid valve regurgitation defined as grade \> 2+ TR
• Aortic valve disease defined as \> 2+ AR or \> moderate AS
• MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization
• Valve replacement or surgical annuloplasty within the past 12 months
• Stroke or transient ischemic attack (TIA) within the past 6 months
• Hemodynamic instability within 30 days of scheduled implant procedure

Sponsors & Collaborators

• Edwards Lifesciences: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: February 22, 2021
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-07