Uriel is also a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons and an Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine. "This clinical study is important in proving the potential benefit of combining CCM therapy, which improves quality of life in patients with heart failure, with gold-standard ICD technology that delivers lifesaving therapy for sudden cardiac death," said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at New York-Presbyterian and National Co-Principal Investigator for the INTEGRA-D trial.
Patients enrolled in the study will receive the Optimizer Integra CCM-D System, and will be followed for at least two years. The study will assess the performance of the CCM-D device in effectively treating episodes of ventricular tachycardia and/or ventricular fibrillation while also providing CCM treatment for heart failure.
Cardiac ipulse trial#
The INTEGRA-D trial is a multicenter study of 300 subjects from 75 centers that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM-D System. "The first implant went well, and we look forward to further studying this device." "We hope combining cardiac contractility modulation therapy and ICD therapy with prolonged battery life will reduce the number of leads and the number of procedures a patient may have to endure," said Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Principal Investigator of the INTEGRA-D trial. "The trial aims to study whether this device can protect heart failure patients from the risk of sudden cardiac death while also treating heart failure symptoms." "The first-in-the-world implant of this novel technology has potential to advance treatments for patients living with heart failure," said Niraj Varma, M.D., Ph.D., electrophysiologist at Cleveland Clinic and National Primary Investigator of the INTEGRA-D clinical trial. The INTEGRA-D trial is the first to evaluate the Optimizer Integra CCM-D System that combines both therapies into a single device, designed to last for many years. Patients indicated for CCM therapy may also be at a higher risk for arrythmias and sudden cardiac arrest and are therefore often offered an ICD to treat their heart for life-threatening arrythmias, should they occur. The journey of a heart failure patient often involves debilitating symptoms and declining quality of life.ĬCM therapy delivered by the Optimizer System improves quality of life and helps patients feel better. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures. The Optimizer ® Integra TM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. MARLTON, N.J., (GLOBE NEWSWIRE) - Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined - CCM ® and an implantable cardioverter defibrillator (ICD) - in a single device (CCM-D).
World's First Device Combining CCM Therapy With an ICD in a Single Rechargeable Implant That Treats Both Heart Failure Symptoms and Sudden Cardiac Death
0 kommentar(er)
