Ignite Creation Date:
2024-05-06 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03628534
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2018-07-26
Brief Title:
SERF VT Ablation Early Feasibility Study EFS
Sponsor:
Thermedical Inc
Organization:
Thermedical Inc
Study Overview
Official Title:
Saline Enhanced Radiofrequency SERF VT Ablation Early Feasibility Study EFS
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERF VT EFS
Brief 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 thats 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R44HL132746-01A1 | NIH | None | httpsreporternihgovquickSearch1R44HL132746-01A1 |