Transvenous Lead Removal Using the Cook Evolution® LEAd Extraction SystEm Post-Market Clinical Study
Completed
- Conditions
- transvenous lead removallead removal / lead extraction
- Registration Number
- NL-OMON48528
- Lead Sponsor
- Cook Research Incorporated
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
A patient is suitable for inclusion in this clinical study if the patient is
treated per the IFUs of the Cook lead extraction devices used and the patient
meets the following criteria:
1. Patients must be 18 years of age or older
2. Lead indwell time greater than 1 year
Exclusion Criteria
Patients shall be excluded from enrollment into the clinical study if any of
the following are true:
1. Patient is unable or unwilling to provide informed consent (per the IRB/EC
requirements) to participate in the clinical study
2. Investigator intends to treat patient with a non-Cook sheath device
3. Patient presents with an extracardiac lead
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of complete procedural success and clinical procedural success in the<br /><br>clinical study. See appendix D (page 33) of the protocol for details.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Major complications<br /><br>• Damage to a non-target lead (other than the lead intended to be removed)<br /><br>• Use of Cook Evolution® RL controlled-rotation dilator sheath set as a first<br /><br>choice during lead extraction procedure<br /><br>• Procedural costs</p><br>