Endosense, a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced enrollment of the first patients in its ProForce Registry. The news marks the launch of the ProForce Registry Study, an international, single arm, multi-center, post-market trial of Endosense's TactiCath force-sensing ablation catheter. Designed to enroll up to 2,000 patients, the ProForce Registry Study will evaluate the use and impact of contact force monitoring during catheter ablation procedures.
“The ProForce Registry reinforces our focus on building clinical evidence along with the increased use of the TactiCath.”
The first patient enrolled in ProForce was treated with the TactiCath at the Princess Grace Hospital in Monaco by Nadir Saoudi, M.D., Ph.D. Commenting on this milestone, Steering Committee Chairman Hein Wellens, M.D., Ph.D., said, "The ProForce Registry Study will give us a good look at the practical impact of contact force sensing in catheter ablation, particularly in the critical areas of technology performance and patient safety. I applaud Endosense for its approach to study the TactiCath in ongoing clinical practice, as it will help generate greater understanding of and confidence in this new technology."
The ProForce Registry Study will gather and assess TactiCath patient data and physician-supplied feedback from numerous worldwide centers. Specific study objectives include:
- Evaluating the clinical usage of contact force measurement during catheter ablation procedures on a large scale
- Monitoring patient safety for post-market surveillance
- Collecting physician feedback and assessing performance of the TactiCath in clinical practice
Endosense will analyze all collected data, including procedural information collected through automatically generated procedure summary reports, a new feature made available with the recent launch of the next generation TactiCath and supporting TactiSys™ system; adverse event reporting forms; and TactiCath experience reporting forms. Third party oversight includes the review and substantial data monitoring by an independent clinical research organization.
"Endosense has long been committed to building the evidence supporting the clinical value of contact force sensing in catheter ablation procedures in terms of effectiveness and safety. Just one of many Endosense studies that are currently underway, ProForce represents our approach to lead market adoption of force control in the clinical practice," said Eric Le Royer, president and chief executive officer of Endosense. "The ProForce Registry reinforces our focus on building clinical evidence along with the increased use of the TactiCath."
The TactiCath force-sensing ablation catheter and the TactiSys system are indicated for the treatment of atrial fibrillation (AF) and supraventricular tachycardia (SVT). BIOTRONIK is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa, and Middle East. The TactiCath is not yet available in the United States.