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Cardiology

Catheterization Laboratory

The cardiac catheterization laboratory participates in multiple multicenter trials that involve the development and assessment of new transcatheter devices and transcatheter treatment modalities for patients with congenital/structural heart disease. The laboratory is also involved in validation studies focused on innovative, non-invasive ways to assess hemodynamic data (such as cardiac output and mixed venous saturation) at the bedside or at ambulatory outpatient evaluations. Finally, the lab is involved in multicenter, safety and efficacy trials for specific devices as well as follow-up registries and outcome assessment protocols.

• Medtronic Melody Transcatheter Pulmonary Valve Trial -- a multicenter, U.S. investigational device exemption (IDE) trial involving use of the Medtronic Melody Transcatheter Pulmonary Valve in right ventricular outflow tract conduit dysfunction. Contact: William E. Hellenbrand, MD
• Medtronic Melody Post-Approval Study Program -- the primary objectives will be to gather data on the long-term clinical performance of the Melody transcatheter pulmonary valve and to assess whether or not the results obtained by the IDE centers have external validity among other centers and patients. The first study will involve continued follow-up through five years, and the second study will involve enrollment of additional subjects to be implanted among 8-10 new centers. Contact: Julie A. Vincent, MD
• Coarctation of Aorta Stent Trial (COAST) -- a multicenter trial involving use of bare metal and covered Cheatham/Platinum (CP) stents for treatment of native and recurrent aortic coarctation under an FDA IDE protocol. Contact: Julie A. Vincent, MD
• Covered Stent Compassionate Use Study -- a multicenter trial involving use of covered Cheatham/Platinum (CP) stents for primary treatment of coarctation of aorta and aortic vascular injuries. Contact: Julie A. Vincent, MD
• AGA ADO II Clinical Study -- a multicenter trial to further assess safety and efficacy of the new Amplatzer Duct Occluder II device (AGA Medical) for transcatheter closure of the patent ductus arteriosus under an FDA IDE protocol. Contact: Julie A. Vincent, MD
• ASD PMS II -- a multi-center post-market approval study involving use of Amplatzer Septal Occluder for transcatheter closure of atrial septal defects to assess long term clinical performance of the Amplatzer Septal Occluder used for transcatheter closure of atrial septal defects. Contact: William E. Hellenbrand, MD
• AGA Muscular VPA study -- a multicenter, post-market approval study involving the AGA Muscular Ventricular Septal Occluder for treatment of muscular ventricular defects. Contact: William E. Hellenbrand, MD
• Congenital Cardiac Catheterization Outcomes Project (C3PO) -- a multicenter study to assess adverse events and outcomes of diagnostic and interventional cardiac catheterizations in congenital heart disease and to report these event rates as a multi-institutional experience rather than the usual report from a single center experience. This data will also aid in the development of tools and assessing methods for risk stratification which will allow equitable comparisons of outcomes among institutions and individual practitioners. Contact: Julie A. Vincent, MD
• Balloon Angioplasty vs. Intravascular Stent Placement for Recurrent or Native Coarctation of the Aorta under the CCISC (Congenital Cardiovascular Interventional Study Consortium) -- a prospective, multicenter observational study involving 41 centers to compare surgical, balloon angioplasty, and stent placement as treatment for coarctation of the aorta in children > 12 kg. Contact: Julie A. Vincent, MD
• Non-invasive Tissue Saturation Monitor as a Surrogate for Mixed Venous Saturation in Children (Validation of Sto2 in Children) -- an institutional study involving collaboration between Neonatology and Cardiology services to evaluate the relationship between tissue saturation as measured by T-Stat (a non-invasive monitor and buccal probe (clip) and oximetrically measured mixed venous saturation from routine blood samples obtained from the SVC and/or PA in patients undergoing cardiac catheterization. Contacts: Ganga Krishnamurthy, MD or Julie A. Vincent, MD
• Validation of noninvasive measurement of cardiac output -- an institutional study involving collaboration between Neonatology and Cardiology services to evaluate the relationship between cardiac output (CO) measured non-invasively by electrical cardiometry with CO measured by thermodilution (TD) method and Fick method in children undergoing cardiac catheterization. Contacts: Ganga Krishnamurthy or Julie A. Vincent, MD
• Detection of Atherosclerosis with Intravascular Ultrasound (IVUS) and Cardiac Computed Tomography Angiography (CCTA) in Familial Hypercholesterolemia: A Comparative Study -- a pilot study to evaluate the presence and severity of coronary and aortic atherosclerosis in patients with homozygous and heterozygous familial hypercholesteremia using IVUS imaging with high resolution coronary CCTA and to assess whether CCTA can allow comparable imaging of coronary artery atherosclerosis with the more invasive "gold standard" IVUS with less risk to the patient. This study is being performed at the Weill Cornell campus. Contacts: Rubin S. Cooper, MD or Julie A. Vincent, MD
• Aortic Balloon Valvuloplasty: Procedural Success, Efficacy and Adverse Events: Results of a Multi-center Registry -- a multicenter study (under C3PO) to assess success, efficacy, and adverse events, and to identify risk factors or variables associated with outcome of aortic balloon valvuloplasty for patients with congenital aortic valve stenosis. Contact: Alejandro J. Torres, MD
• Pulmonary Balloon Valvuloplasty: Procedural Success, Efficacy and Adverse Events: Results of a Multi-center Registry -- a multi-center study (under C3PO) to assess success, efficacy, and adverse events, and to identify risk factors or variables associated with outcome of pulmonary balloon valvuloplasty for patients with congenital pulmonary valve stenosis. Contact: Alejandro J. Torres, MD

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