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

XTRAC

Status: Enrolling

Conditions: Bradycardia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06115980

XTR-01-0322

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 upon current guidelines.
4. Lead implant duration more than 1 year and less than 5 years.
5. Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
6. Patients are classified as ASA II/III.
7. Leads with external diameter of 7Fr-9Fr.

Exclusion criteria

1. Patient age > 85 years old.
2. Hemodynamic instability.
3. Class IV NYHA heart failure.
4. Contrast allergy.
5. Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
6. Patients who are placed on a heparin bridge, and are felt to be high risk for even brief discontinuation of anticoagulation
7. Pregnant or lactating.
8. 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1 - An open label study

Experimental group

Description:

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.

Treatment:

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