Arrhythmias & electrophysiologyCohort study
Ultra-Low Cryoablation for Scar-Related Ventricular Tachycardia (VT) Ablation: Results From the US Early Feasibility Study
- prospective, nonrandomized evaluation
- EFS (Early Feasibility Study)
- designed in collaboration with the Food and Drug Administration
- 4 clinical sites
Authors' conclusion
In a US EFS, ULTC therapy was safe and effective for the treatment of scar-related VT. The EFS design, in collaboration with the Food and Drug Administration, represents an important initiative to accelerate the evaluation of new medical technologies in the United States.
Study context
- Population
- Patients with scar-related VT undergoing VT ablation with ultra-low temperature cryoablation (ULTC)underwent VT ablation with ULTC from September to December 2023 at 4 clinical sites
- Participants
- Twenty patients
Main finding
As reported in the abstract
Noninducibility of the targeted VTs · postablation
ULTC
13 of 14
events
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Freedom from VT · 23.7±4.3 weeks · among surviving per-protocol patients | ULTC 61.1% |
| Freedom from implantable cardioverter defibrillator shock · 23.7±4.3 weeks · among surviving per-protocol patients | ULTC 83.3% |
Procedural characteristics
- Mean ULTC lesions
- 9.9±3.6
- Total freeze duration
- 47±22 minutes
Follow-up completeness
- One patient was excluded from the follow-up efficacy analysis due to RF use
- another lacked postacute follow-up due to death from heart failure 1 month post-procedure
Safety
| Outcome | Values |
|---|---|
| Suspected cardiac perforation without tamponade · conservatively managed | ULTC One events |
| Death from heart failure · 1 month post-procedure | ULTC One events |
Procedural strokes, tamponades, or deaths
- There were no procedural strokes, tamponades, or deaths
Original publication
Ultra-Low Cryoablation for Scar-Related VT Ablation: Results From the US Early Feasibility Study. Circ Arrhythm Electrophysiol. Published 2 February 2026. doi:10.1161/circep.125.014095
Summarised from the published abstract; every number is checked against it