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SERF VT Ablation Early Feasibility Study (EFS)

NCT03628534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-08-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Saline Enhanced Radiofrequency (SERF) ablation

Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Thermedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Packer, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-06-30
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03628534 on ClinicalTrials.gov