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

NCT06115980 | Recruiting

• 1 other identifier: XTR-01-0322
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

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

  0 to 30 days post-lead extraction

Secondary Outcomes (3)

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

  During procedure

• To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years

  Acute setting (during the surgical procedure)

• To evaluate the rate of clinical procedural success

  Acute setting (during the surgical procedure)

Study Arms (1)

1 - An open label study

EXPERIMENTAL

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. A total of 15 patients, who are scheduled for lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up.

Device: lead extraction (Xtrac O.S. system)

Interventions

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

1 - An open label study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xtrac O.S.: lead
• KCRI: collaborator
• Scopus Research: collaborator

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Uri Stein, PhD

CONTACT

+972525801916; uri@xtrac-medical.com

Liron Hason, Bsc

CONTACT

+972543838100; Liron.h@scopus-cro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. A total of 10 patients, who are scheduled for lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up. 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.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: November 3, 2023
• Study Start: August 27, 2023
• Primary Completion: May 15, 2025
• Study Completion: July 20, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

IL (1)