Trial results for the DiamondTemp™ Ablation System for the treatment of persistent atrial fibrillation were posted on ClinicalTrials.gov on 2025-10-23. The study reported an improvement in AFEQT Quality of Life scores from a baseline of 61.6 to 88.0 at 12-month follow-up.
Background
Atrial Fibrillation (AF) is a common cardiac arrhythmia. Persistent atrial fibrillation is a more challenging form to manage, often requiring interventions beyond initial pharmacological approaches. The DiamondTemp Ablation System was investigated for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients who have not responded adequately to medication.
Trial design
The Diamond-AF II study (NCT03643224) was a completed trial with an enrollment of 376 participants. The study investigated the DiamondTemp Ablation System for the treatment of Persistent Atrial Fibrillation and Atrial Fibrillation. The trial phase was not specified (NA). The study aimed to establish the safety and effectiveness of the system for drug refractory, symptomatic persistent atrial fibrillation.
Key results
The study reported several key measurements for the Modified Intention-to-treat (mITT) Cohort:
- Primary Safety Events: 16 participants
- Primary Effectiveness: 198 participants
- Freedom From a Composite of Serious Adverse Events (SAEs): 273 participants
- Freedom From Documented AF/AFL/AT Episodes: 188 participants
- Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy: 126 participants
- Acute Procedural Success: 289 participants
- Single Procedure Success With Freedom From AF/AT/AFL: 172 participants
- Single Procedure Success With Freedom From All Primary Effectiveness Failures: 155 participants
- AFEQT Quality of Life, Baseline: mean score of 61.6 on a scale
- AFEQT Quality of Life, 6-month Follow-up: mean score of 85.6 on a scale
- AFEQT Quality of Life, 12-month Follow up: mean score of 88.0 on a scale
- Change in AFEQT Quality of Life From Baseline to 12-month: mean change of 26.5 on a scale
What this means
The results indicate that the DiamondTemp Ablation System demonstrated both safety and effectiveness outcomes in patients with persistent atrial fibrillation. Notably, the AFEQT Quality of Life scores showed a substantial improvement, rising from a baseline mean of 61.6 to 88.0 at 12-month follow-up, with a mean change of 26.5. This suggests a positive impact on the patient's perceived quality of life. The reported 16 primary safety events and 198 participants achieving primary effectiveness provide specific metrics for clinicians to consider regarding the system's performance.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03643224, titled "DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation", were posted on 2025-10-23 on clinicaltrials.gov.