NCT03628534

SERF VT Ablation Early Feasibility Study (EFS)

Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Thermedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.

Detailed description

The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablate™ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.

Conditions

• Ventricular Tachycardia
• Arrythmia
• Heart Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Saline Enhanced Radiofrequency (SERF) ablation	Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-06-30
• Completion: 2022-07-31
• First posted: 2018-08-14
• Last updated: 2022-08-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study