Clinical Trials (active)

Principal Investigator:
Lawrence Ang, MD

This is a prospective, multi-center, randomized, sham-controlled clinical trial.

The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)

Principal Investigator:
Ehtisham Mahmud, MD, FACC, MSCAI

To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.

A non-randomized single-arm will further assess the safety and effectiveness of the Neovasc Reducer System in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects with reversible myocardial ischemia without documented obstructive coronary disease and subjects who cannot complete an exercise tolerance test due to an above-the-ankle amputation.

Principal Investigator:
Ehtisham Mahmud, MD, FACC, MSCAI

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.

Principal Investigator:
Ehtisham Mahmud, MD, FACC, MSCAI

This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.

Principal Investigator:
Ehtisham Mahmud, MD, FACC, MSCAI

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved.

Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

Principal Investigator:
Ehtisham Mahmud, MD, FACC, MSCAI

This is a single center observational registry that will collect information on treatment strategies and outcomes of consecutive patients who undergo balloon pulmonary angioplasty. The study will not affect the standard of care, but merely record the techniques and outcomes of those procedures. There is no new treatment procedure proposed in the study. Patients will undergo treatment according to the current standard of care guidelines.

Individuals with chronic clots in the blood vessels that supply the lungs, depending on their ineligibility for surgical treatment can undergo a procedure called Balloon Pulmonary Angioplasty (BPA) which can open the occlusions and narrowing of these vessels.

In this procedure, a catheter is advanced trough one of the two internal jugular veins or one of the two femoral veins towards the pulmonary artery. Then, the diseased segment of the pulmonary circulation is crossed with a wire and the narrowing is dilated with small balloons inflated gently to avoid the vessel wall damage to restore the normal blood flow in the diseased vessel. There are several factors that influence successful recanalization of the blocked vessel.  These factors include demographic features of the patient; characteristics, length, and severity of the blocked vessel; different approaches to reopen the vessel; the utilization of various crossing tools and devices and operator experience. In all patients multiple procedures are required and scheduled at a various time interval one from each other to ensure a complete restoration of blood flow in all the occluded or narrowed vessels of the pulmonary circulation.