Is NCT06445608 recruiting in Hartford, CT?

Yes, NCT06445608 is currently recruiting participants at its Hartford, CT location. This coronary artery disease clinical trial is actively enrolling qualified participants.

How do I join the coronary artery disease clinical trial in Hartford?

To join this clinical trial in Hartford, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Hartford clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Coronary Artery Disease Clinical Trial in Hartford, CT

Who Can Participate

Inclusion Criteria

Subject age ≥ 18 and ≤ 90 years at the time of screening

The subject has an LV ejection fraction of \< 50% (within 90 days of index procedure) AND is at high-risk due to any of the following:

Unprotected left main coronary artery stenosis disease

Last remaining epicardial native coronary artery

Significant three vessel coronary artery disease

Significant two vessel coronary artery disease of complex lesions

Significant single vessel coronary artery disease of complex lesions and non-treated CTO

Target vessel is a CTO with planned retrograde approach

Intended calcium modification (by atherectomy, lithotripsy or laser)

In multiple vessels OR

In the left main OR

In a final patent conduit OR

Where the anatomic SYNTAX score is ≥32

Local heart team (interventional cardiologist, cardiac surgeon) has determined that the subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System

Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound

The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations

The subject has been informed of the nature of the trial, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion Criteria

Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure

STEMI within 7 days prior to index procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest leads or the limb leads

Non-STEMI within 7 days prior to index procedure with an elevated cardiac biomarker (CK-MB or Troponin \>1x ULN) without CK-MB or Troponin value down trending

Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation

Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy

Current left ventricular thrombus

Significant right heart failure (right ventricular fractional area change \<35% on echocardiography)

Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization \> 70mmHg

Combined cardiorespiratory failure

Presence of an atrial or ventricular septal defect (including post-infarct VSD)

Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis

Cardiogenic shock (Cardiac index \< 1.8 L/min/m2)

Use of inotropic or pressor therapy within 72 hours of the planned index procedure. NOTE: Use of inotropic or pressor therapy for the sole purpose of blood pressure support associated with anesthesia for the procedure is acceptable.

Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure

Severe aortic valve insufficiency or stenosis or aortic valve replacement

Clinically-relevant vascular disease that precludes the placement of a MCS device

Cerebrovascular Accident (CVA) within 180 days prior to index procedure

Transient Ischemic Attack (TIA) within 90 days prior to index procedure

Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)

Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia

Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics

Active infection of the intended access site

Chronic renal dysfunction (eGFR \< 30 mL/min/1.73 m²) and/or patients requiring renal replacement therapy with dialysis

KnownHistory of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to index procedure

Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 \< 1.0 L/s)

Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)

Any non-cardiac condition with life expectancy \< 1 year

Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \> 24 hours with full neurologic recovery). Procedure-related intubation is acceptable.

Decompensated heart failure requiring IV diuretics, vasopressors or inotropic support within 72 hours of index procedure

Patients with an organ transplant

Patients with implanted left ventricular assist device

Cardiac tamponade

Left ventricular rupture

Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation

Any anatomical restriction that would preclude a MCS device from being delivered through the femoral artery to the left ventricle

Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures

Current participation in another investigational drug or device trial

Anticipated need for continued MCS support after conclusion of the PCI procedure

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hartford?

Yes, this clinical trial (NCT06445608) has an active research site in Hartford, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Coronary Artery Disease Treatment Options in Hartford, CT

If you're searching for coronary artery disease treatment options in Hartford, CT, this clinical trial (NCT06445608) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hartford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced coronary artery disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all coronary artery disease clinical trials near you to find additional studies recruiting in your area.

Coronary Artery Disease Clinical Trial in Hartford, CT

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About This Coronary Artery Disease Study in Hartford