Prospective Registry on User Experience With The Mapping... | NCT02698670

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2016

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Feb 24, 2016

First Submission Date that Met QC Criteria

Feb 29, 2016

First Posted Date

Mar 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

577Actual

Name	Type	Description	Arm Group Labels	Other Names
Rhythmia mapping system	Device	A 3-D Cardiac Mapping system
IntellaMap Orion mapping catheter	Device	A diagnostic basket mapping catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Hoag Memorial Hospital

ID	Term
D001145	Arrhythmias, Cardiac
D002318	Cardiovascular Diseases

ID	Term
D006331	Heart Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms