Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Ehtisham Mahmud, MD

Description

Summary

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

Official Title

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

Details

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.

Keywords

Heart Failure Transcatheter Atrial Shunt System Edwards Transcatheter Atrial Shunt System

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  4. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory NYHA class IV AND
  5. ≥ 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.
  6. 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
  7. 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
  8. Willing to attend study follow-up assessments for up to 5 years

Inclusion Criteria for RV Overload group only:

I1B. Pulmonary Hypertension (PH) that maybe reversible, documented by the following:

  1. Pulmonary Vascular Resistance (PVR) > 4 Wood Units at rest AND
  2. Mean Pulmonary Artery Pressure (mPAP) ≥ 25 mmHg at rest AND
  3. Successful reversibility of PH under a resting Sodium Nitroprusside challenge where success is defined as a lowering of the PVR by ≥ 20% to a level < 4 Wood Units while maintaining a Systolic Blood Pressure ≥ 90 mmHg

You CAN'T join if...

  1. Severe heart failure defined as one or more of the below:
  2. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
  3. If BMI < 30, Cardiac index < 2.0 L/min/m2
  4. If BMI ≥ 30, cardiac index < 1.8 L/min/m2
  5. Inotropic infusion (continuous or intermittent) within the past 6 months
  6. Patient is on the cardiac transplant waiting list
  7. LVEF < 20%
  8. Presence of significant valve disease defined by the site cardiologist as:
  9. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS
  10. Tricuspid valve regurgitation defined as grade > 2+ TR
  11. Aortic valve disease defined as > 2+ AR or > moderate AS
  12. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization
  13. Valve replacement or surgical annuloplasty within the past 12 months
  14. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA) within the past 6 months
  15. Hemodynamic instability within 30 days of scheduled implant procedure
  16. Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
  17. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)
  18. 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
  19. . Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
  20. . Performance of the 6 minute walk test with a distance <50m OR >600m
  21. . Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy
  22. . Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
  23. . Known hypersensitivity to Nickel and/or Tantalum
  24. . In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
  25. . In the opinion of the investigator, the subject is not an appropriate candidate for the study
  26. . Anatomy (including implantable devices) that is not compatible with the Edwards Transcatheter Atrial Shunt System
  27. . Active endocarditis or infection within 3 months of scheduled implant procedure
  28. . 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.
  29. . Patient is a current intravenous drug user
  30. . 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
  31. . Patient is under guardianship
  32. . Known pre-existing shunting, determined to be clinically significant by the investigator
  33. . (Not applicable to RV Overload group) Right ventricular dysfunction, defined by the site cardiologist as:
  34. More than mild RV dysfunction as estimated by TTE; OR
  35. TAPSE <1.4 cm; OR
  36. RV size ≥ LV size as estimated by TTE; OR
  37. Echocardiographic or clinical evidence of congestive hepatopathy
  38. . Evidence of pulmonary hypertension with PVR >4 Wood units

Exclusion Criteria for RV Overload group only:

E1B. 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. Right Atrial Pressure (RAP) > 18 mm Hg; OR
  5. Echocardiographic or clinical evidence of congestive hepatopathy;

Locations

  • UC San Diego Health accepting new patients
    La Jolla California 92037 United States
  • University of Colorado accepting new patients
    Aurora Colorado 80045 United States

Lead Scientist at UCSD

  • Ehtisham Mahmud, MD
    Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 214 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03523416
Study Type
Interventional
Participants
Expecting 55 study participants
Last Updated