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New treatment option for Heart Failure
Official title A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
ClinicalTrials.gov ID: NCT06147336
What this study is testing
- What it's testing
- The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 88
You may be able to join if
- Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection...
- NYHA Class II heart failure (HF) people, documented at Baseline Visit regardless of ejection fraction, meeting both in subsections (2a) and (2b) or...
- Have a minimum of one (1) HF hospitalization or equivalent (HF Emergency Department Visit or HF Urgent Clinic Visit) within the last 12 months...
- Have a corrected\ elevated outpatient Brain Natriuretic Peptide (BNP) level of at least 300 pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at...
- Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 20 kg/m2. If the subject is on ARNI...
You likely can't join if
- Initial Exclusion Criteria (IEC):
- Age less than 22 (\<22) years old.
- people who are NYHA class IV and ACC/AHA stage D.
- people with evidence/history of a major cardiovascular or neurovascular event, such as an intra-cardiac thrombus or history of stroke, transient...
- people with a resting systolic blood pressure \ 180 mmHg at Baseline Visit.
- Left ventricular end-diastolic diameter (LVEDD) \> 8cm.
See the full eligibility criteria
Who can join
- Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction.
- NYHA Class II heart failure (HF) people, documented at Baseline Visit regardless of ejection fraction, meeting both in subsections (2a) and (2b) or NYHA Class III heart failure (HF) people, documented at Baseline Visit...
- Have a minimum of one (1) HF hospitalization or equivalent (HF Emergency Department Visit or HF Urgent Clinic Visit) within the last 12 months associated with signs/symptoms of congestion requiring treatment with...
- Have a corrected\ elevated outpatient Brain Natriuretic Peptide (BNP) level of at least 300 pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500 pg/ml, according to local measurement, within 90-days of the...
- Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 20 kg/m2. If the subject is on ARNI, NT-proBNP should be used exclusively.
- Receiving maximally-tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT), in the absence of contraindications and lack of...
- For patient with heart failure and a reduced ejection fraction (HFrEF), GDMT includes a diuretic as needed for volume control, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or...
- For patient with heart failure and a preserved ejection fraction (HFpEF), GDMT includes a diuretic as needed for volume control and treatment of associated conditions (e.g., hypertension, atrial fibrillation) for at...
- Patients should also receive Class I recommended cardiac rhythm management device therapy. Specifically: if indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator...
- GDMT may change over time; the most current versions of the ACC/AHA or ESC Heart Failure Guidelines will supersede the above guidelines.
- Minimum technological knowledge of either the subject or the caregiver, with a smartphone or tablet for use of the self-management application, including physical ability and access to internet.
- Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits. 6.5.2.
What rules you out
- Initial Exclusion Criteria (IEC):
- Age less than 22 (\<22) years old.
- people who are NYHA class IV and ACC/AHA stage D.
- people with evidence/history of a major cardiovascular or neurovascular event, such as an intra-cardiac thrombus or history of stroke, transient ischemic attack, systemic or pulmonary thromboembolism, deep vein...
- people with a resting systolic blood pressure \ 180 mmHg at Baseline Visit.
- Left ventricular end-diastolic diameter (LVEDD) \> 8cm.
- Have an atrial septal defect or patent foramen ovale with more than trace shunting on color Doppler or intravenous bubble study or surgical or treatment correction of congenital heart disease involving atrial septum...
- people with untreated severe valve lesions, which are indicated for surgical or percutaneous intervention, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked...
- Uncontrolled tachyarrhythmia or bradycardia (heart rate \<45 bpm).
- Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D), including people receiving continuous or intermittent outpatient IV vasoactive medications (e.g., IV inotropes, IV...
- Intolerant to ACE-I, ARB, or ARNI and beta-blocker medical therapy for people classified as HFrEF.
- The presence of an acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), rhythm management system revision, lead extraction, or cardiac or other major surgery within the preceding 90 days of implant...
- people not eligible for emergency open-heart, thoracic or vascular surgery.
- Women who are pregnant or planning to become pregnant.
- people with a life expectancy that is shorter than 12 months, or those who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months of Baseline Visit.
- Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.
- Known history of life-threatening allergy to contrast dye that cannot be properly pre-medicated.
- Have an estimated Glomerular Filtration Rate (GFR) \<25 ml/min/1.73 m2 by the MDRD method or on chronic renal dialysis.
- Hepatic impairment with at least one liver Function Test (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
- Gastrointestinal bleeding in the last 6 months of implant procedure.
- Have severe chronic pulmonary disease requiring continuous home oxygen, chronic oral steroid therapy, hospitalization for exacerbation during prior 6 months, or has severe obstructive physiology on PFTs (FEV1/FVC \<0.70...
- people who have an active infection requiring systemic antibiotics or an elevated white blood count (above the local laboratory reference ranges).
- Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
- Are currently participating in a clinical study or investigation.
- Subject otherwise not appropriate for study as determined by the investigator and people who are unwilling to comply with the study protocol, or people with a history of non-compliance. The reasons must be documented.
- people contraindicated for trans-septal puncture, TEE or ICE. Intra Procedural Exclusion Criteria: (Intra Procedural Exclusion Criteria will be determined immediately after intracardiac echocardiography or...
- Anatomical anomaly on TEE or ICE that precludes implantation of the V-LAPIM across the interatrial septum (Fossa Ovalis) including: Septal thickness at fossa \> 5 mm, FO Dimension \<16mm, ASD or PFO with more than a...
- Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate a right heart catheterization (RHC).
- Severe pulmonary hypertension at index procedure above 70 mmHg or PVR at index procedure above 4.0 Woods Units (mmHg L-1 min-1), while these cannot be lowered with vasodilators.
- Resting systolic Blood Pressure \ 180 mmHg, not corrected with IV fluid administration or vasodilators.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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, 22 years to 88 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.