Clinical trial data further demonstrate safety and effectiveness of RHYTHMIA mapping system

Data from the TRUE-HD study has been announced during a late-breaking clinical trial session at the annual congress of the European Heart Rhythm Association (EHRA) in Barcelona, Spain. The data demonstrated the RHYTHMIA Mapping System, when paired with the INTELLAMAP ORION Mapping Catheter, continues to be safe and effective for mapping and to support treatment of a wide variety of arrhythmias, including a cohort of patients who had unsuccessful ablation of atrial fibrillation using other techniques.

The global TRUE-HD study examined procedural process, acute success and safety for the mapping and ablation of various clinical arrhythmias. Depending on the arrhythmia type, study data showed an acute success rate of up to 95.7%. In 222 patients, procedure process included the creation of validation maps to confirm the termination of an arrhythmia. Utilisation of the RHYTHMIA Mapping System vMap feature allowed physicians to rapidly assess therapy efficacy and determine if other arrhythmias were present. When completed, validation mapping identified the need for additional ablations in 73.0% of patients.

“This study was the first to perform systematic data collection on a range of arrhythmia types using the RHYTHMIA Mapping System,” said Gerhard Hindricks, principal investigator and head of the electrophysiology department at Leipzig University Heart Center in Germany. “Importantly, validation mapping allowed for precise views of therapy success and the identification of new areas in the heart requiring additional ablations that would have otherwise gone untreated.”

The observational, prospective, non-randomized study enrolled 572 patients eligible for cardiac mapping and ablation to treat an arrhythmia, with the exception of those diagnosed with de novo atrial fibrillation. The ablation-related complications were low and similar to those reported in recent literature¹, with only 0.57% potentially related to the mapping catheter.

References

1. Haegeli LM, Catheter ablation of atrial fibrillation: an update. Eur Heart J., 2014(36): p. 2454-9.