Prospective Registry on User Experience With The Mapping System For Ablation Procedures

Cardiac Arrhythmias Clinical Trial

— TRUE-HD  

Official title:

Prospective Registry on User Experience With The Mapping System For Ablation Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698670
• Other study ID #: 91118280
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: January 23, 2018
• Start date: May 25, 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Device:
• Rhythmia mapping system
A 3-D Cardiac Mapping system
• IntellaMap Orion mapping catheter
A diagnostic basket mapping catheter

Locations

Country	Name	City	State
Australia	Wesley Medical Research	Brisbane	Queensland
France	CHU de Bordeaux	Pessac
France	Centre Hôpital Universitaire Rangueil	Toulouse
Germany	Universitaetsklinik Eppendorf	Hamburg
Germany	Herzzentrum Universität Leipzig	Leipzig
Hong Kong	Queen Mary Hospital	Hong Kong
Netherlands	University Medical Center Groningen	Groningen
Spain	Clinica Universitaria de Navarra	Pamplona
United Kingdom	Harefield Hospital	London
United Kingdom	The Brompton Hospital	London
United States	University of Michigan Hospitals	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	University of Chicago Hospital	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Riverside Methodist - Ohio Health	Cincinnati	Ohio
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Baptist Memorial Hosptial	Memphis	Tennessee
United States	Maimonidies Hospital	New York	New York
United States	Heart Rhythm Institute	Oklahoma City	Oklahoma
United States	Hoag Memorial Hospital	Orange	California
United States	Oregon Health Sciences University	Portland	Oregon
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Torrance Memorial Medical Center	Torrance	California
United States	Trinity Mother Francis	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Hong Kong,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Procedural Success	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)