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Recruiting NCT06115980

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

No phase Interventional Bradycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lead extraction (Xtrac O.S. system).
Who it may be relevant to
Registry conditions: Bradycardia. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

First in Man, Open-label, Multi Center Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

Overview

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.

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 extra

Primary outcome measures

  • To evaluate safety related to the lead extraction procedure, or the extraction tool [Time frame: 0 to 30 days post-lead extraction]
Secondary outcome measures (3)
  • To assess the ease of use, duration of the procedure and the physician satisfaction by questions by a Likert scale [Time frame: During procedure]
  • To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years [Time frame: Acute setting (during the surgical procedure)]
  • To evaluate the rate of clinical procedural success [Time frame: Acute setting (during the surgical procedure)]

Eligibility criteria

Inclusion criteria

  • Men or Female patients, 18-85 years old.
  • 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.
  • Scheduled for a CIED lead extraction upon current guidelines.
  • Lead implant duration more than 1 year and less than 5 years.
  • Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
  • Patients are classified as ASA II/III.
  • Leads with external diameter of 7Fr-9Fr.

Exclusion criteria

  • Patient age > 85 years old.
  • Hemodynamic instability.
  • Class IV NYHA heart failure.
  • Contrast allergy.
  • Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
  • Patients who are placed on a heparin bridge, and are felt to be high risk for even brief discontinuation of anticoagulation
  • Pregnant or lactating.
  • Participating in another clinical study.

Eligibility will be determined by the PI and investigators based on the exclusion/inclusion criteria, current medical status and evaluation of the procedure risks mitigation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Israel · 1 center
  • Hadassah Medical Center — Jerusalem

Identifiers

NCT: NCT06115980 · XTR-01-0322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗