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COMPLETED

Transvenous Lead Removal Post-Market Clinical Study

NCT03688412 · View on ClinicalTrials.gov ↗

Study 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

Conditions Studied

Interventions

  • DEVICE Cook lead extraction devices

Study Locations (9)

Other

  • German Heart Center Berlin — Berlin
  • Isala — Zwolle
  • St. George's University Hospital — London

California

  • UCSF Medical Center — San Francisco

Illinois

  • Carle Foundation — Urbana

North Carolina

  • NC Heart and Vascular Reseach — Raleigh

Pennsylvania

  • Wellspan York Hospital — York

Texas

  • Memorial Hermann — Houston

Virginia

  • University of VA Medical Center — Charlottesville

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2018-10-18
Est. Completion 2020-05-11

Sponsor

Cook Research Incorporated

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03688412

The ClinicalTrials.gov registry entry for NCT03688412 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cook Research Incorporated, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cardiac Electrophysiology appearing as the primary indexed condition, and to 1 intervention — of which Cook lead extraction devices is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03688412 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03688412 about?

NCT03688412 is a clinical study titled "Transvenous Lead Removal Post-Market Clinical Study". 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 ...

What is the current status of trial NCT03688412?

This trial is currently completed. The enrollment target is 230 participants. The study started on 2018-10-18. Estimated completion is 2020-05-11.

What conditions does trial NCT03688412 study?

This clinical trial studies the following conditions: Cardiac Electrophysiology. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03688412?

The interventions under investigation include: Cook lead extraction devices (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03688412?

This trial is sponsored by Cook Research Incorporated, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03688412 being conducted?

This trial has 9 study locations across California, Illinois, North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial