Clinical trial for Heart Failure
Official title Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System
ClinicalTrials.gov ID: NCT07858799
What this study is testing
- What it's testing
- The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance for future clinical study and system designs utilizing the APTURE system.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Refined HFrEF Subgroup
- A primary diagnosis of HFrEF (LVEF ≤ 40%), and
- NYHA Class II, III, or IVa heart failure symptoms and
- Hospitalization for heart failure; or
- Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
You likely can't join if
- 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
See the full eligibility criteria
- Refined HFrEF Subgroup
- A primary diagnosis of HFrEF (LVEF ≤ 40%), and
- NYHA Class II, III, or IVa heart failure symptoms and
- 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.
- Stable Optimized GDMT- Maintained 6 months post-implant (includes stable GLP-1 RA), indicated device therapy, and comorbidity management. Refined HFrEF Subgroup
- 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, or unmet guideline-directed indication for CRT
- 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 \ 450 m
- Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
- Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
- Mean right atrial pressure (RAP) \>15 mmHg
- Mean PCWP-mean RAP gradient \< 5 mmHg
- Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
- Cardiac index \<1.8 L/min/m2
- Baseline resting heart rate \>100 bpm
The study team makes the final eligibility decision.
Where it is enrolling
- Dresden, Germany, Germany
- Mainz, Germany, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dresden, Germany, Germany; Mainz, Germany, Germany. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.