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NCT03628534: SERF VT EFS
SERF VT Ablation Early Feasibility Study (EFS)
NA trial testing Saline Enhanced Radiofrequency (SERF) ablation in Ventricular Tachycardia in 16 participants. Completed in 31 July 2022.
30 June 2021
Quick facts
| Lead sponsor | Thermedical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 November 2018 |
| Primary completion | 30 June 2021 |
| Estimated completion | 31 July 2022 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Saline Enhanced Radiofrequency (SERF) ablation
Conditions studied
- Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
- Arrythmia — all drugs for Arrythmia →
- Heart Diseases — all drugs for Heart Diseases →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
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):
-
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 -
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:
- PubMed search for NCT03628534
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ventricular Tachycardia
Currently open trials in the same condition.
- NCT07201506 — Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation · NA · recruiting
- NCT06360939 — Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease · NA · recruiting
- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT06891456 — Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia · NA · recruiting
- NCT06592001 — Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study · NA · active not recruiting
Other Thermedical, Inc. trials
Trials by the same sponsor.
- NCT05337241 — Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03628534 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thermedical, Inc.
- Last refreshed: 10 August 2022
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