Early Feasibility Study - Transcatheter Atrial Shunt System

Heart Failure Clinical Trial

— ALt FLOW US  

Official title:

EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial Shunt System (ALt FLOW US)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03523416
• Other study ID #: 2018-02
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: December 2026

Study information

• Verified date: December 2022
• Source: Edwards Lifesciences
• Contact: Natalie Alon
• Phone: 949-250-1898
• Email: natalie_alon[@]edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed and dated IRB approved study consent form prior to study related procedures

2. = 18 years old

3. Chronic symptomatic Heart Failure (HF) documented by the following:

1. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory NYHA class IV AND

2. = 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 prior to study entry.

4. 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 Guidelines and that is expected to be maintained without change for 3 months

5. At rest: elevated LAP or PCWP pressure of > 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg AND/OR during supine ergometer exercise stress test, as measured at end-expiration, elevated LA (or PCWP) pressure of > 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by > 10 mmHg

6. Willing to attend study follow-up assessments for up to 5 years

Inclusion Criteria for Cohort B, Heart Failure with Pulmonary Vascular Disease only:

1. Pulmonary Vascular Resistance (PVR) > 3.0 and = 8.0 Wood Units at rest

2. Mean Pulmonary Artery Pressure (mPAP) = 25 mmHg at rest AND

3. If baseline PVR is > 4.0, must show successful reversibility of PH under a resting Sodium Nitroprusside* challenge where success is defined as a lowering of the PVR to a level = 4.0 Wood Units while maintaining a Systolic Blood Pressure = 90 mmHg.

• Equivalent vasodilator agent (e.g., nitric oxide) may be used as deemed appropriate per hospital practice

Exclusion Criteria:

1. Severe heart failure defined as one or more of the below:

1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF

2. If BMI < 30, Cardiac index < 2.0 L/min/m2

3. If BMI = 30, cardiac index < 1.8 L/min/m2

4. Inotropic infusion (continuous or intermittent) within the past 6 months

5. Patient is on the cardiac transplant waiting list

6. LVEF < 20%

2. Presence of significant valve disease defined by the site cardiologist as:

1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS

2. Tricuspid valve regurgitation defined as grade > 2+ TR

3. Aortic valve disease defined as > 2+ AR or > moderate AS

3. MI and/or any therapeutic invasive, non-valvular cardiac procedure within past 3 months or current indication for coronary revascularization

4. Surgical valve repair or replacement within the past 12 months; Transcatheter valve repair or replacement within the past 6 months.

5. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA) within the past 6 months

6. Hemodynamic instability within 30 days of scheduled implant procedure

7. Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure

8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)

9. Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis

10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase

11. Performance of the 6 minute walk test with a distance <50m OR >600m

12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy

13. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated

14. Known hypersensitivity to Nickel and/or Tantalum

15. In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons

16. In the opinion of the investigator, the subject is not an appropriate candidate for the study

17. Anatomy (including implantable devices) that is not compatible with the Edwards Transcatheter Atrial Shunt System

18. Active endocarditis or infection within 3 months of scheduled implant procedure

19. Currently participating (e.g., undergoing trial specific exams/treatment/procedures) in an investigational drug or device study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials.

20. Patient is a current intravenous recreational drug user

21. Positive serum pregnancy test in female subjects of child-bearing potential or nursing mothers or planning on becoming pregnant during the duration of the trial

22. Patient is under guardianship

23. Known pre-existing shunting, determined to be clinically significant by the investigator

24. (Not applicable to Cohort B) Right ventricular dysfunction, defined by the site cardiologist as:

1. More than mild RV dysfunction as estimated by TTE; OR

2. TAPSE <1.4 cm; OR

3. RV size = LV size as estimated by TTE; OR

4. Echocardiographic or clinical evidence of congestive hepatopathy

25. Evidence of pulmonary vascular disease with PVR >3.0 Wood units

Exclusion Criteria for Cohort B, Heart Failure with Pulmonary Vascular Disease only:

1. Propensity for increased Right ventricular dysfunction, defined by the site cardiologist as:

1. More than moderate RV dysfunction as estimated by TTE; OR

2. TAPSE <1.2 cm; OR

3. RV size = LV size as estimated by TTE; OR

4. Mean Right Atrial Pressure (RAP) > 18 mm Hg; OR

5. Echocardiographic or clinical evidence of congestive hepatopathy

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Transcatheter Atrial Shunt System
Transcatheter treatment of symptomatic left heart failure patients

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	The Christ Hospital	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	St. Vincent Medical Group	Indianapolis	Indiana
United States	University of Florida Health - Jacksonville	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	UC San Diego Health	La Jolla	California
United States	Abbott Northwestern	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University California San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at 30 days.		30 days
Secondary	Device Success	Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room.	Day 0
Secondary	Procedural Success	Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values.	10 days post-op
Secondary	Clinical Success	Procedural success without major adverse cardiac, cerebrovascular, or renal events (MACCRE) or re-intervention for study device related complications at 30 days.	30 days
Secondary	Performance/Effectiveness	Comparison vs baseline of Qp/Qs value	Baseline, 3 months, 6 months
Secondary	Performance/Effectiveness	Improvement vs baseline of PCWP under the same test conditions (e.g. rest, legs raised, exercise)	Baseline, 3 months, 6 months
Secondary	Performance/Effectiveness	Change in mean, systolic & diastolic pulmonary artery pressure (PAP) and mean right atrial pressure (RAP) under the same test conditions	Baseline, 3 months, 6 months
Secondary	Performance/Effectiveness	Change in PVR under the same test conditions	Baseline, 3 months, 6 months
Secondary	Performance/Effectiveness	Change in TAPSE, TAPSE/sPAP	Baseline, 3 months, 6 months