A randomized controlled clinical trial evaluating the safety and efficacy of a radiofrequency ablation transseptal puncture system

Transseptal puncture (TSP) is a critical technique for left-heart interventional therapies, widely used in cardiac catheter ablation, left atrial appendage closure, and mitral valve interventions. Conventional mechanical puncture systems face limitations such as technical complexity, steep learning curves, and high risks in challenging TSP procedures. Radiofrequency (RF) ablation-assisted transseptal puncture may enhance needle stability through thermal energy application. This study aimed to evaluate the safety and efficacy of a novel radiofrequency ablation transseptal puncture system.

This prospective, multicenter, randomized controlled non-inferiority trial enrolled patients undergoing left-heart radiofrequency ablation via TSP. Participants were randomized 1:1 to the experimental group (RF system) or control group (mechanical system). The RF system featured an integrated puncture needle, guidewire, and RF generator, with enhanced intracardiac echocardiography visibility for sheaths, needles, and guidewires. The primary efficacy endpoint was TSP success rate. Secondary endpoints included puncture time, crossover rate after failure, and device performance. Safety endpoints comprised adverse events (AEs) and complications.

A total of 181 patients from four centers were enrolled (experimental group: n=91; control group: n=90). Males comprised 52.5%, with a mean age of 68.3 years. The primary endpoint success rate was 98.9% (90/91) in the experimental group and 100% (90/90) in the control group, demonstrating non-inferiority (95% CI lower limit >−10%; P >0.05). Mean puncture time was significantly shorter in the experimental group (7.8±5.4 s vs. 144.6±242.3 s; P <0.001). AE rates were 38.89% (35/91) and 35.56% (32/90) in the experimental and control groups, respectively, with no severe device-related complications.

The novel RF ablation transseptal puncture system demonstrated superior procedural efficiency and operability compared to conventional mechanical systems, highlighting its high clinical value.

RFA transseptal puncture system