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NCT Number: NCT06115980

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

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, Israel

Location status: Recruiting

Location contact

Yair Elitzur, M.D

CONTACT

[email protected]

02-6773401

Yair Elitzur, M.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lead extraction (Xtrac O.S. system)

Device

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

Primary outcomes

  1. To evaluate safety related to the lead extraction procedure, or the extraction tool

    Time frame: 0 to 30 days post-lead extraction

    To collect and evaluate device- and procedure-related adverse events.

Secondary outcomes

  1. To assess the ease of use, duration of the procedure and the physician satisfaction by questions by a Likert scale

    Time frame: During procedure

    Using Likert scale (1 - Poor; 2 - Fair; 3 - Good; 4 - Excellent)

  2. 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)

    Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death

  3. To evaluate the rate of clinical procedural success

    Time frame: Acute setting (during the surgical procedure)

    Clinical procedural success is the removal of all targeted leads and all lead material from the vascular space, or retention of a small portion of the lead (fragment that is 4 cm or smaller) that does not negatively impact the outcome goals of the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Liron Hason, Bsc

CONTACT

[email protected]

+972543838100

Uri Stein, PhD

CONTACT

[email protected]

+972525801916

Sponsors and collaborators

Lead sponsor

Xtrac O.S.

Industry

Collaborators

  • KCRI
  • Scopus Research

Registry information

Official study title

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

Acronym: XTR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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