Brief Summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
Brief Title
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
Detailed Description
The early feasibility study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
949-250-1898
Central Contact Email
Natalie_Alon@edwards.com
Central Contact Role
Contact
Central Contact Phone
949-250-2002
Central Contact Email
melissa_arteaga@edwards.com
Completion Date
Completion Date Type
Estimated
Conditions
HEART FAILURE
Eligibility Criteria
Refined HFrEF Subgroup Inclusion Criteria:
* A primary diagnosis of HFrEF (LVEF ≤ 40%), and
* NYHA Class II, III, or IVa heart failure symptoms and
* Documentation of at least one of the following in the past 12 months, such as:
* Hospitalization for heart failure; or
* Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
* Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.
Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.
* Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)
Refined HFrEF Subgroup Exclusion Criteria:
* Severe HF defined as one or more of the following:
* Ambulatory NT-proBNP value \>5,000 pg/ml or BNP value \>1,600 pg/ml
* Left ventricular end-diastolic diameter (LVEDD) \>8 cm
* Left ventricular ejection fraction (LVEF) \< 20%
* ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
* Inotropic infusion (continuous or intermittent) within the past 6 months
* Active listing on the cardiac transplant waiting list
* More than mild right ventricular dysfunction
* Valve disease
* Mitral regurgitation \> moderate
* Mitral stenosis \> mild
* Tricuspid regurgitation \> moderate
* Aortic regurgitation \> moderate
* Aortic stenosis \> moderate
* Body mass index (BMI) ≥45
* Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
* Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
* Cardiac resynchronization therapy implanted within the past 12 months
* Renal insufficiency as determined by serum creatinine (sCr) level \>2.5 mg/dL or estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73 m2
* Performance of the 6-minute walk test with a distance \<100 m or \>450 m
* Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
* Presence of one or more of the following resting hemodynamic findings:
1. Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
2. Mean right atrial pressure (RAP) \>15 mmHg
3. Mean PCWP-mean RAP gradient \< 5 mmHg
4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
5. Cardiac index \<1.8 L/min/m2
* A primary diagnosis of HFrEF (LVEF ≤ 40%), and
* NYHA Class II, III, or IVa heart failure symptoms and
* Documentation of at least one of the following in the past 12 months, such as:
* Hospitalization for heart failure; or
* Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
* Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.
Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.
* Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)
Refined HFrEF Subgroup Exclusion Criteria:
* Severe HF defined as one or more of the following:
* Ambulatory NT-proBNP value \>5,000 pg/ml or BNP value \>1,600 pg/ml
* Left ventricular end-diastolic diameter (LVEDD) \>8 cm
* Left ventricular ejection fraction (LVEF) \< 20%
* ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
* Inotropic infusion (continuous or intermittent) within the past 6 months
* Active listing on the cardiac transplant waiting list
* More than mild right ventricular dysfunction
* Valve disease
* Mitral regurgitation \> moderate
* Mitral stenosis \> mild
* Tricuspid regurgitation \> moderate
* Aortic regurgitation \> moderate
* Aortic stenosis \> moderate
* Body mass index (BMI) ≥45
* Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
* Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
* Cardiac resynchronization therapy implanted within the past 12 months
* Renal insufficiency as determined by serum creatinine (sCr) level \>2.5 mg/dL or estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73 m2
* Performance of the 6-minute walk test with a distance \<100 m or \>450 m
* Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
* Presence of one or more of the following resting hemodynamic findings:
1. Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
2. Mean right atrial pressure (RAP) \>15 mmHg
3. Mean PCWP-mean RAP gradient \< 5 mmHg
4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
5. Cardiac index \<1.8 L/min/m2
Inclusion Criteria
Inclusion Criteria:
* A primary diagnosis of HFrEF (LVEF ≤ 40%), and
* NYHA Class II, III, or IVa heart failure symptoms and
* Documentation of at least one of the following in the past 12 months, such as:
* Hospitalization for heart failure; or
* Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
* Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.
Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.
* Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)
Refined HFrEF Subgroup
* A primary diagnosis of HFrEF (LVEF ≤ 40%), and
* NYHA Class II, III, or IVa heart failure symptoms and
* Documentation of at least one of the following in the past 12 months, such as:
* Hospitalization for heart failure; or
* Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
* Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.
Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.
* Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)
Refined HFrEF Subgroup
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03523416
Org Class
Industry
Org Full Name
Edwards Lifesciences
Org Study Id
2018-02
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)
Primary Outcomes
Outcome Description
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Outcome Measure
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Outcome Time Frame
30 days
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Day 0
Outcome Measure
Rate at which device is successfully implanted (Device Success)
Outcome Description
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.
Outcome Time Frame
10 days post-op
Outcome Measure
Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)
Outcome Description
Procedural success without major adverse cardiac, cerebrovascular, renal events (MACCRE), and re-intervention for study device related complications at 30 days.
Outcome Time Frame
30 days
Outcome Measure
Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)
Outcome Description
Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month)
Outcome Time Frame
3 months, 6 months
Outcome Measure
Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up
Outcome Description
Improvement in PCWP value from Baseline to Follow Up (3Month, 6Month)
Outcome Time Frame
3 months, 6 months
Outcome Measure
Improvement in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up
Outcome Description
Change in PAP and RAP values from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)
Outcome Time Frame
3 months, 6 months
Outcome Measure
Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up
Outcome Description
Change in PVR value from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)
Outcome Time Frame
3 months, 6 months
Outcome Measure
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up
Outcome Description
Change in two parameters from Baseline to Follow Up (3Month, 6Month): 1. "TAPSE", Tricuspid Annular Plane Excursion 2. "TAPSE/sPAP", Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP)
Outcome Time Frame
3 months, 6 months
Outcome Measure
Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ulrich Jorde
Investigator Email
ujorde@montefiore.org
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- HEART FAILURE
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
HEART FAILURE
HEART DISEASES
CARDIOVASCULAR DISEASES