Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Recruiting
N/A
Interventional Study
Bradycardia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 10 (estimated)
- Sponsor
- Xtrac O.S. · Industry
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About This Trial
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.
A total of 15 patients, who are scheduled for CIED lead extraction, will be recruited in order to ensure a total of at least 10 patients finis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Men or Female patients, 18-85 years old.
2. Patients must understand the procedures and methods of this study and be willing to sign the informed consent form and to complete the trial in strict accordance with clinical trial protocol.
3. Scheduled for a CIED lead extraction …
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