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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02698670




Registration number
NCT02698670
Ethics application status
Date submitted
24/02/2016
Date registered
4/03/2016
Date last updated
25/01/2018

Titles & IDs
Public title
Prospective Registry on User Experience With The Mapping System For Ablation Procedures
Scientific title
Prospective Registry on User Experience With The Mapping System For Ablation Procedures
Secondary ID [1] 0 0
91118280
Universal Trial Number (UTN)
Trial acronym
TRUE-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrhythmias 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Rhythmia mapping system
Treatment: Devices - IntellaMap Orion mapping catheter

Treatment: Devices: Rhythmia mapping system
A 3-D Cardiac Mapping system

Treatment: Devices: IntellaMap Orion mapping catheter
A diagnostic basket mapping catheter

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
At the end of the index procedure (Day 0)

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Wesley Medical Research - Brisbane
Recruitment postcode(s) [1] 0 0
4001 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
France
State/province [15] 0 0
Pessac
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Netherlands
State/province [20] 0 0
Groningen
Country [21] 0 0
Spain
State/province [21] 0 0
Pamplona
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an observational, prospective, non-randomized, multicenter, post approval study being
conducted in the United States, Europe and Asia-Pacific Regions.
Trial website
https://clinicaltrials.gov/show/NCT02698670
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerhard Hindricks
Address 0 0
Gerhard Hindricks
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications