Prospective Registry on User Experience With The Mapping System For Ablation Procedures (TRUE-HD)

January 23, 2018 updated by: Boston Scientific Corporation
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system.

The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.

Study Type

Observational

Enrollment (Actual)

577

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4001
        • Wesley Medical Research
  • France
      • Pessac, France, 33604
        • CHU de Bordeaux
      • Toulouse, France, 31059
        • Centre Hôpital Universitaire Rangueil
  • Germany
      • Hamburg, Germany, 20251
        • Universitaetsklinik Eppendorf
      • Leipzig, Germany
        • Herzzentrum Universität Leipzig
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen
  • Spain
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Harefield Hospital
      • London, United Kingdom, SW3 6NP
        • The Brompton Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Orange, California, United States, 92868
        • Hoag Memorial Hospital
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospitals
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New York
      • New York, New York, United States, 11219
        • Maimonidies Hospital
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital of the University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 43214
        • Riverside Methodist - Ohio Health
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Heart Rhythm Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Tennessee
      • Memphis, Tennessee, United States, 38138
        • Baptist Memorial Hosptial
    • Texas
      • Tyler, Texas, United States, 75701
        • Trinity Mother Francis
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion

Description

Inclusion Criteria:

  • Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion;
  • Subjects who are willing and capable of providing informed consent;
  • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
  • Subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  • Subjects requiring de novo ablation of atrial fibrillation;
  • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility*;
  • The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
  • Subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment;
  • Unrecovered/unresolved Adverse Events from any previous invasive procedure;
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Procedural Success
Time Frame: At the end of the index procedure (Day 0)
Primary endpoint is the acute procedural success for the primary arrhythmia in the whole cohort of ablation procedures. A procedure will be defined successful if all the following conditions will occur during the case: 1) ability to map, 2) completion of the necessary ablation applications, 3) primary arrhythmia termination (when applicable), and 4) validation of ablation through appropriate technique(s).
At the end of the index procedure (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Gerhard Hindricks, Gerhard Hindricks

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 25, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91118280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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