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Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

NCT06115980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-13

No results posted yet for this study

Summary

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 finishing the study procedures and follow up.

Conditions

  • Bradycardia

Interventions

DEVICE

lead extraction (Xtrac O.S. system)

This is an open label, non-randomized, feasibility, prospective, interventional 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. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA). Each enrolled patient will undergo a pre procedural evaluation to enable planning of the extraction procedure. The evaluation includes an assessment of the CIED components to be removed, dwell time, anatomic course on radiography and patient characteristics that may require management prior to extraction. A multidisciplinary team evaluation involving cardiac surgery, electrophysiologist, and cardiac anesthesiology should allow for a rapid and successful response to major complications

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Scopus Research

    collaborator UNKNOWN

  • Xtrac O.S.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-27
Primary Completion
2025-05-15
Completion
2025-07-20

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06115980 on ClinicalTrials.gov