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NCT03628534: SERF VT EFS

SERF VT Ablation Early Feasibility Study (EFS)

Completed NA Last updated 10 August 2022
What this trial tests

NA trial testing Saline Enhanced Radiofrequency (SERF) ablation in Ventricular Tachycardia in 16 participants. Completed in 31 July 2022.

Timeline
1 November 2018
Primary endpoint
30 June 2021
31 July 2022

Quick facts

Lead sponsorThermedical, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date1 November 2018
Primary completion30 June 2021
Estimated completion31 July 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Thermedical, Inc.

Who can join

18 and older, any sex, with Ventricular Tachycardia or Arrythmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial.
    Packer DL, Wilber DJ, Kapa S, Dyrda K, et al · · 2022 · cited 25× · PMID 35776711 · DOI 10.1161/circep.121.010347
  2. Solving the Reach Problem: A Review of Present and Future Approaches for Addressing Ventricular Arrhythmias Arising from Deep Substrate.
    Ravi V, Winterfield J, Liang J, Larsen T, et al · · 2023 · cited 3× · PMID 37600155 · DOI 10.15420/aer.2022.28

Verify or expand the search:

Other recruiting trials for Ventricular Tachycardia

Currently open trials in the same condition.

Other Thermedical, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03628534.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing