Medical device industry heavy-weight Medtronic (NYSE:MDT) entered a collaboration agreement with ARCA biopharma, providing continuous cardiac monitoring of patients undergoing experimental treatment with a genetically targeted cardiovascular drug therapy.
Medtronic will help support the GENETIC-AF clinical trial, a phase 2b/3 study comparing the experimental Gencaro drug to an established cardiovascular drug in preventing atrial fibrillation in patients with heart failure and reduced left ventricular ejection fraction.
Gencaro, a genetically targeted therapy, is designed for patients with a specific genetic variant of the beta-1 cardiac receptor. ARCA plans to enroll 200 patients in the Phase 2b arm of the study and expand to an additional 420 patients by Phase 3, depending on the results of interim analyses.
All 200 initial study participants enrolled during the Phase 2b arm will undergo heart rhythm monitoring with a Medtronic device, either a previously implanted system or a new Reveal loop recorder implant, according to a press release. The implants will measure the patients’ actual atrial fibrillation, regardless of symptoms.
Medtronic will manage device implantation, use, monitoring, data collection and analysis. If the GENETIC-AF study proceeds to Phase 3, researchers hope to add an additional 100 patients to the AF burden study.
The medtech titan has long been a primary player in cardiac rhythm management, but has suffered some blows as pricing pressures and other environmental factors have slowed the market. The CRM market appears to have stabilized, Medtronic CFO Gary Ellis told investors last month, but it’s unlikely to return to previous levels of growth.