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Transvenous Lead Removal Post-Market Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688412
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Study Description
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Brief Summary:
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations

Condition or disease Intervention/treatment
Cardiac Electrophysiology Device: Cook lead extraction devices

Study Design
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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.
Actual Study Start Date : October 18, 2018
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : May 11, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cook lead extraction devices
The Cook lead extraction devices are indicated for use in patients requiring percutaneous removal of CIED leads, indwelling catheters and foreign objects.
 Device: Cook lead extraction devices
The Cook lead extraction devices are mechanical devices that encompass a full variety of devices required for percutaneous removal of CIED leads, indwelling catheters and foreign objects.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of complete procedural success [ Time Frame: Immediately following lead extraction ]
    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.

  2. Rate of clinical procedural success [ Time Frame: Immediately following lead extraction ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring percutaneous removal of Cardiovascular Implantable Electronic Device (CIED) leads
Criteria

Inclusion Criteria:

  1. Patients must be 18 years of age or older
  2. Lead indwell time greater than 1 year

Exclusion Criteria:

  1. Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study
  2. Patient presents with an extracardiac lead
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688412


Locations
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United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
United States, Illinois
Carle Foundation
Urbana, Illinois, United States, 61801
United States, North Carolina
NC Heart and Vascular Reseach
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Wellspan York Hospital
York, Pennsylvania, United States, 17403
United States, Texas
Memorial Hermann
Houston, Texas, United States, 77030
United States, Virginia
University of VA Medical Center
Charlottesville, Virginia, United States, 22908
Germany
German Heart Center Berlin
Berlin, Germany
Netherlands
Isala
Zwolle, Netherlands
United Kingdom
St. George's University Hospital
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Cook Research Incorporated
More Information
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT03688412    
Other Study ID Numbers: 16-04
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Cardiac pacing, artificial
Cardiac Resynchronizaton Therapy Devices
Defibrillators, Implantable