Phase 2 Heart Disease Trial, Recruiting (NCT06851949)

Phase 2 Heart Disease Trial, Recruiting NCT06851949 Sponsor: Cardiac Success Condition: Heart Disease

Printed from Voxsanity (voxsanity.com.au) — NCT06851949 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Heart Disease

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Adults aged 18 or older
People whose left ventricle (the heart's main pumping chamber) is enlarged, measuring 55mm or more at its most relaxed point
People whose heart is pumping between 20% and 40% of its capacity (known as ejection fraction)
People with mild or no leaking of the mitral valve (the valve between the left heart chambers), confirmed by an ultrasound of the heart
People where the distance between two specific internal heart muscles measures 20mm or more, as seen on a heart ultrasound
People with moderate to severe heart failure symptoms (classified as NYHA Class II to IVa) (confirm with trial site)
People whose heart muscle disease is caused either by blocked arteries or by other causes unrelated to blocked arteries
People who understand what the study involves and are able to sign a written consent form

Who may not be able to join:

People who have structural damage to the cords or leaflets of the mitral valve
People who have had a dangerous fast heart rhythm (ventricular tachycardia or ventricular fibrillation) in the 6 months before joining
People who have previously had mitral valve repair or replacement surgery
People who had a heart device (such as a pacemaker, defibrillator, or cardiac resynchronisation device) implanted within the 3 months before joining
People who showed signs of the heart being unable to pump enough blood to the body (cardiogenic shock) within the 30 days before joining
People whose heart or blood vessel anatomy, in the treating doctor's opinion, would make it unsafe to pass the study device through
People with severe narrowing of the aortic valve
People with very severe leaking of the tricuspid valve (the valve on the right side of the heart) that requires surgical or catheter-based repair
People with high blood pressure in the lungs (pulmonary hypertension) that does not improve with medication, where the pressure is above 70 mmHg
People who had a heart attack (with a specific type called ST-elevation) within the 30 days before joining
People born with certain heart defects (some minor defects may be acceptable — confirm with trial site)
People whose heart failure is caused by a condition called amyloidosis or other stiffening diseases of the heart muscle
People with serious kidney disease, defined by high creatinine levels in the blood (3.0 mg/dL or above) or those already on kidney dialysis
People who had any invasive heart procedure within the 30 days before the study procedure
People who had heart surgery within the 3 months before joining
People who had a stroke within the 90 days before joining
People with abnormal platelet counts in the blood — either too low (below 100,000/mm³) or too high (above 750,000/mm³)
People who had a body temperature above 38°C within 3 days before the study procedure
People with bleeding disorders or conditions that cause the blood to clot too easily
People with an active stomach ulcer or gastrointestinal bleeding within the 90 days before the planned procedure
People who cannot take blood-thinning or anti-clotting medications
People with known allergies to stainless steel, nickel, titanium, or contrast dye used in imaging, where the allergy cannot be adequately managed beforehand
People with known serious reactions to medications used during the procedure, where these cannot be adequately managed medically
People currently taking part in another clinical trial for an investigational drug or device that has not yet completed its main study goals, or that may interfere with this study
People with other serious health conditions that, in the treating doctor's opinion, mean they are not expected to live for at least 12 months
People with other health conditions that, in the treating doctor's opinion, may affect their ability to take part fully in the study or to attend follow-up appointments
People who are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 6 July 2026

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +972 (52) 5989833

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06851949

Sponsor: Cardiac Success

Phase: Phase 2

Status: Recruiting

Condition: Heart Disease

Trial contact: +972 (52) 5989833

More information: https://clinicaltrials.gov/study/NCT06851949

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Adults aged 18 or older
People whose left ventricle (the heart's main pumping chamber) is enlarged, measuring 55mm or more at its most relaxed point
People whose heart is pumping between 20% and 40% of its capacity (known as ejection fraction)
People with mild or no leaking of the mitral valve (the valve between the left heart chambers), confirmed by an ultrasound of the heart
People where the distance between two specific internal heart muscles measures 20mm or more, as seen on a heart ultrasound
People with moderate to severe heart failure symptoms (classified as NYHA Class II to IVa) (confirm with trial site)
People whose heart muscle disease is caused either by blocked arteries or by other causes unrelated to blocked arteries
People who understand what the study involves and are able to sign a written consent form

Who may not be able to join:

People who have structural damage to the cords or leaflets of the mitral valve
People who have had a dangerous fast heart rhythm (ventricular tachycardia or ventricular fibrillation) in the 6 months before joining
People who have previously had mitral valve repair or replacement surgery
People who had a heart device (such as a pacemaker, defibrillator, or cardiac resynchronisation device) implanted within the 3 months before joining
People who showed signs of the heart being unable to pump enough blood to the body (cardiogenic shock) within the 30 days before joining
People whose heart or blood vessel anatomy, in the treating doctor's opinion, would make it unsafe to pass the study device through
People with severe narrowing of the aortic valve
People with very severe leaking of the tricuspid valve (the valve on the right side of the heart) that requires surgical or catheter-based repair
People with high blood pressure in the lungs (pulmonary hypertension) that does not improve with medication, where the pressure is above 70 mmHg
People who had a heart attack (with a specific type called ST-elevation) within the 30 days before joining
People born with certain heart defects (some minor defects may be acceptable — confirm with trial site)
People whose heart failure is caused by a condition called amyloidosis or other stiffening diseases of the heart muscle
People with serious kidney disease, defined by high creatinine levels in the blood (3.0 mg/dL or above) or those already on kidney dialysis
People who had any invasive heart procedure within the 30 days before the study procedure
People who had heart surgery within the 3 months before joining
People who had a stroke within the 90 days before joining
People with abnormal platelet counts in the blood — either too low (below 100,000/mm³) or too high (above 750,000/mm³)
People who had a body temperature above 38°C within 3 days before the study procedure
People with bleeding disorders or conditions that cause the blood to clot too easily
People with an active stomach ulcer or gastrointestinal bleeding within the 90 days before the planned procedure
People who cannot take blood-thinning or anti-clotting medications
People with known allergies to stainless steel, nickel, titanium, or contrast dye used in imaging, where the allergy cannot be adequately managed beforehand
People with known serious reactions to medications used during the procedure, where these cannot be adequately managed medically
People currently taking part in another clinical trial for an investigational drug or device that has not yet completed its main study goals, or that may interfere with this study
People with other serious health conditions that, in the treating doctor's opinion, mean they are not expected to live for at least 12 months
People with other health conditions that, in the treating doctor's opinion, may affect their ability to take part fully in the study or to attend follow-up appointments
People who are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 6 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 2

Sponsor

Cardiac Success

Registry

ClinicalTrials.gov

Start date

15 November 2024

Est. completion

1 January 2026

Where this trial is recruiting

🇮🇱 Israel

Primary endpoints

Device related Serious Adverse Events (SAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov