Clinical trials: Lead Insulation Failure
Lead Insulation Failure
Therapy Coil Electrogram Collection Study
This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead…
- Trial name
- TEC (NCT02314598)
- Testing
- No treatment
- Where
- 2 sites in Slovakia
- Volunteers
- 46 people
- Sponsor
- Medtronic BRC
Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT Device, to Which is Attached a St. Jude Riata Lead
Insulation Failure in St. Jude Riata Leads
A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months.
- Trial name
- NCT02095977
- Testing
- fluoroscopy, synchronized high-voltage shock, Holter monitor
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hartford Hospital