Multi-center Complex Atrial Tachycardia High-Resolution M... | NCT03613831

Studies
Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)

NCT03613831

Sponsor

Boston Scientific Corporation

Status

Withdrawn

Last Update Posted

Sep 1, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery

Interventions

patient who used Rhythmia system and Orion catheter

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The sponsor has decided to stop the study

Expanded Access Info

Start Date

Dec 2020Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Jul 30, 2018

First Posted Date

Aug 3, 2018Actual

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

Aug 31, 2020

Last Update Posted Date

Sep 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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 study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patient who used Rhythmia system and Orion catheter	Device	suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion

Measure	Description	Time Frame
target patient's type	Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery.	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment;
Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
Subject is age 18 or above;
Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail.

Exclusion Criteria:

Subject with atrial fibrillation only;
Subject is enrolled in any other concurrent study that might interfere with this study;
Women of childbearing potential who are or might be pregnant at the time of this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

An arbitrary sample size of 100 should be enough for this registry study which may cover the focal, macro-reentry, micro-reentry and other types of atrial tachycardia. Assuming that the one-year recurrence rate post complex atrial tachycardia ablation is 30%, the 95% confidence interval of 100 samples shall be 21.2-40.0% (binomial distribution exact method).

As per the current actual situation in China, it is predicted that 70-80 cases may be included for the atrial tachycardia post atrial fibrillation ablation, while 20-30 cases may be included for post cardiac surgery.

Sampling Method

Probability Sample