Ischemic mitral regurgitation is estimated to affect 2.8 million Americans. CTSN has conducted two companion trials: the severe ischemic mitral regurgitation trial (SMR trial, NCT00807040) evaluated the effectiveness and safety of mitral valve repair versus replacement in severe ischemic mitral regurgitation patients; the moderate ischemic mitral regurgitation trial (MMR trial, NCT00806988) evaluated the addition of mitral valve repair to coronary bypass surgery alone in moderate ischemic mitral regurgitation patients. We recently reported on a trial evaluating the value of repairing the tricuspid valve in patients undergoing mitral valve surgery who had moderate or less tricuspid regurgitation (TVR trial; NCT02675244). Patients with degenerative mitral valve disease are the focus of an ongoing CTSN trial comparing surgical mitral valve repair to transcathether edge-to-edge repair.
CTSN evaluated the value of surgical ablation in treating patients with chronic persistent atrial fibrillation undergoing mitral valve surgery (AF trial; NCT00903370). Post-operative atrial fibrillation is the most common complication following cardiac surgery. We compared whether rate or rhythm control medications were superior in managing post-operative atrial fibrillation in cardiac surgery patients. Currently, CTSN is evaluating the role of anticoagulation in preventing thrombo-embolic events in patients who experience post-operative atrial fibrillation following coronary bypass surgery (PACeS trial; NCT04045665). CTSN is launching a trial to evaluate the effectiveness and safety of posterior pericardiotomy to reduce the frequency of post-operative atrial fibrillation in patients undergoing coronary and valvular surgery.
Since coronary revascularization remains the most common surgical procedure, we conducted a trial of external venous coronary graft stent to reduce risk of graft occlusion (VEST trial; NCT03209609), as well as a trial of hybrid coronary revascularization vs percutaneous coronary intervention in patients with multi-vessel cardiac artery disease (HYBRID trial; NCT03089398).
CTSN has conducted two translational and early phase trials of direct intra-myocardial injection of mesenchymal precursor cells in left ventricular assist device recipients in improving cardiac function (LVAD trials; NCT01442129, NCT02362646).
Neurological complications are among the most dreaded complications after cardiac surgery. CTSN evaluated the effectiveness and safety of embolic protection devices for reducing brain injury during surgical aortic valve replacement. CTSN is conducting a follow-up trial of a modified embolic protection device to reduce the risk of stroke, delirium and kidney injury in high-risk valve patients.
Monoclonal Antibodies & Anti-Viral Therapies in Hospitalized COVID-19 patients
To understand the possible role of neutralizing monoclonal antibodies and other antiviral interventions in patients hospitalized for COVID-19, the National Institutes of Health established the ACTIV-3 (Therapeutics for Inpatients with COVID-19) platform, for conducting efficient trials. CTSN has participated in designing and conducting the ACTIV-3 trials. ACTIV3/TICO is designed as a platform for simultaneous blinded placebo-controlled randomized trials of therapeutics in hospitalized COVID-19 patients, utilizing a shared control group.