Trial results for the Multi-Electrode Radiofrequency Balloon Catheter (HELIOSTAR) in treating symptomatic paroxysmal atrial fibrillation were posted on ClinicalTrials.gov on 2025-08-15. The main study demonstrated an acute procedural success rate of 98.8 percentage of participants and a 12-month alternative success rate of 69.6 percentage of participants.
Background
Atrial fibrillation (AFib) is a common cardiac arrhythmia characterized by irregular and often rapid heart rate, which can lead to symptoms such as palpitations, shortness of breath, and fatigue. It also increases the risk of stroke. For patients with symptomatic paroxysmal atrial fibrillation that is refractory to drug therapy, catheter ablation procedures are a standard treatment option aimed at restoring normal heart rhythm and improving quality of life. This trial evaluated a specific multi-electrode radiofrequency balloon catheter designed for such procedures.
Trial design
This was a Phase 3 clinical investigation that enrolled 397 participants with atrial fibrillation. The primary objective was to demonstrate the safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation. The study evaluated the HELIOSTAR Catheter, with no specific comparator arm mentioned as the design focused on evaluating the device's performance.
Key results
The study reported on several key measurements, distinguishing between a roll-in phase and the main study:
- Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter:
- Roll-in Phase: 4 participants
- Main Study: 13 participants
- Number of Participants With Effectiveness Success:
- Roll-in Phase: 62 participants
- Main Study: 170 participants
- Percentage of Participants With Acute Procedural Success:
- Roll-in Phase: 100 percentage of participants
- Main Study: 98.8 percentage of participants
- Percentage of Participants With Alternative 12-Month Success:
- Roll-in Phase: 67.7 percentage of participants
- Main Study: 69.6 percentage of participants
- Percentage of Participants With 12-Month Symptomatic Recurrence:
- Roll-in Phase: 75.3 percentage of participants
- Main Study: 74.3 percentage of participants
- Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score:
- Roll-in Phase: Mean 33.37 (Standard Deviation 23.275) score on a scale
- Main Study: Mean 35.90 (Standard Deviation 21.754) score on a scale
What this means
The results suggest that the Multi-Electrode Radiofrequency Balloon Catheter (HELIOSTAR) demonstrates a high rate of acute procedural success, with 98.8 percentage of participants in the main study achieving this outcome. The alternative 12-month success rate of 69.6 percentage of participants indicates sustained effectiveness for a significant proportion of patients. The low number of primary adverse events within seven days post-procedure (13 participants in the main study) points to a favorable safety profile. Additionally, the observed improvement in quality of life scores suggests a meaningful clinical benefit for patients undergoing this ablation procedure for symptomatic paroxysmal atrial fibrillation.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03683030, titled "Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation", were posted on 2025-08-15 on clinicaltrials.gov.