Impulse Dynamics has today 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—cardiac contractility modulation (CCM) and an implantable cardioverter defibrillator (ICD)—in a single device (CCM-D).
The Optimizer Integra 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. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.
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 INTEGRA-D trial is the first to evaluate the Optimizer Integra CCM-D system that combines both therapies into a single device.
“The first-in-the-world implant of this novel technology has potential to advance treatments for patients living with heart failure,” said Niraj Varma (Cleveland Clinic, London, UK) and primary investigator of the INTEGRA-D clinical 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.”
“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 (Cleveland Clinic, London, UK), fellow principal investigator of the INTEGRA-D trial. “The first implant went well, and we look forward to further studying this device.”
The INTEGRA-D trial is a multicentre study of 300 subjects from 75 centres that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM-D system. 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. Patients enrolled in the study will receive the Optimizer Integra CCM-D system, and will be followed for at least two years.
“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 (New York-Presbyterian, New York City, USA) and co-principal Investigator for the INTEGRA-D trial.
“Today’s announcement is another example of our commitment to a continuous pace of innovation to build a comprehensive platform in interventional heart failure and help improve the lives of many patients that suffer from this debilitating disease,” said Simos Kedikoglou, chief executive officer of Impulse Dynamics. “We are proud to partner with physicians at leading centres around the world to conduct important research on this first-of-its-kind rechargeable combination device designed to address a major unmet need of a large patient group.”