Brief Summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Brief Title
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
Detailed 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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Heart Failure
Eligibility Criteria
Inclusion Criteria:
* Symptomatic Heart Failure (HF):
* NYHA class II with a history of \> II; III; or ambulatory IV AND
* ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; 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.
* On stable Guideline Directed Medical Therapy (GDMT) for heart failure
* At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* Pulmonary Vascular Resistance (PVR) \< 4.0 WU
Exclusion Criteria:
* Severe HF:
* Stage D, non-ambulatory NYHA Class IV, transplant list
* If BMI \< 30, Cardiac index \< 2.0 L/min/m2
* If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
* Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
* LVEF \< 20%
* Valve disease: MR \> 3+ or \> moderate MS, TR \> 2+, AR \> 2+ or \> moderate AS
* MI or therapeutic invasive cardiac procedure \< 3 months
* TIA, stroke, CRT implanted \< 6 months
* RV dysfunction \> mild by TTE OR TAPSE \< 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25%
* Dialysis OR renal dysfunction (S-CR \> 2.5 mg/dl OR eGFR \< 25 ml/min/1.73m2)
* 6MWT \< 50m OR \> 600m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg at rest
* Body Mass Index (BMI) ≥ 45 kg/m2
* Symptomatic Heart Failure (HF):
* NYHA class II with a history of \> II; III; or ambulatory IV AND
* ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; 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.
* On stable Guideline Directed Medical Therapy (GDMT) for heart failure
* At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* Pulmonary Vascular Resistance (PVR) \< 4.0 WU
Exclusion Criteria:
* Severe HF:
* Stage D, non-ambulatory NYHA Class IV, transplant list
* If BMI \< 30, Cardiac index \< 2.0 L/min/m2
* If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
* Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
* LVEF \< 20%
* Valve disease: MR \> 3+ or \> moderate MS, TR \> 2+, AR \> 2+ or \> moderate AS
* MI or therapeutic invasive cardiac procedure \< 3 months
* TIA, stroke, CRT implanted \< 6 months
* RV dysfunction \> mild by TTE OR TAPSE \< 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25%
* Dialysis OR renal dysfunction (S-CR \> 2.5 mg/dl OR eGFR \< 25 ml/min/1.73m2)
* 6MWT \< 50m OR \> 600m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg at rest
* Body Mass Index (BMI) ≥ 45 kg/m2
Inclusion Criteria
Inclusion Criteria:
* Symptomatic Heart Failure (HF):
* NYHA class II with a history of \> II; III; or ambulatory IV AND
* ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; 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.
* On stable Guideline Directed Medical Therapy (GDMT) for heart failure
* At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* Pulmonary Vascular Resistance (PVR) \< 4.0 WU
* Symptomatic Heart Failure (HF):
* NYHA class II with a history of \> II; III; or ambulatory IV AND
* ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; 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.
* On stable Guideline Directed Medical Therapy (GDMT) for heart failure
* At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* Pulmonary Vascular Resistance (PVR) \< 4.0 WU
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
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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, and 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
Change in PCWP value from Baseline to Follow Up (3Month, 6Month)
Outcome Time Frame
3 months, 6 months
Outcome Measure
Change 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
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
HEART FAILURE
HEART DISEASES
CARDIOVASCULAR DISEASES