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Ventricular Wall Motion Characterization

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01629160
Collaborator
(none)
30
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. Echo will be performed preoperatively and patients will receive a 1-month followup telephone call.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterization of Normal and Abnormal Ventricular Wall Motion
    Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of Ventricular Wall Motion Characterization [Mapping and Ablation Procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Be in sinus rhythm

    • Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations

    • Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy

    Exclusion Criteria:

    • Have permanent AF

    • Exhibit Cheyne-Stokes respiration

    • Have a recent myocardial infarction within 40 days prior to enrollment

    • Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures

    • Have had a recent CVA or TIA within 3 months prior to enrollment

    • Be less than 18 years of age

    • Be pregnant

    • Be currently participating in any other clinical investigation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herzzentrum Leipzig GmbH Leipzig Germany

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Gerhard Hindricks, MD, Herzzentrum Leipzig GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01629160
    Other Study ID Numbers:
    • 642
    First Posted:
    Jun 27, 2012
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Tachycardia
    Tachycardia, Ventricular

    Study Results

    No Results Posted as of Feb 4, 2019