Ripple Mapping for Epicardial Mapping of Brugada Syndrome | NCT03435393

Studies
Ripple Mapping for Epicardial Mapping of Brugada Syndrome

NCT03435393

Sponsor

University College London Hospitals

Status

Unknown status

Last Update Posted

Feb 19, 2018Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Brugada Syndrome

Interventions

Catheter ablation

Countries

Brazil
Portugal
United Kingdom

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Feb 9, 2018

First Submission Date that Met QC Criteria

Feb 9, 2018

First Posted Date

Feb 19, 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

Feb 15, 2018

Last Update Posted Date

Feb 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rui Providência, Honorary Consultant, MD PhD, University College London HospitalsPrincipal Investigator

Lead Sponsor

University College London HospitalsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.

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

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catheter ablation	Procedure	Mapping of the epicardium and ablating areas of long fractionated potentials

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eradication of Brugada syndrome pattern	Disappearance of type 1 Brugada pattern on post-procedure ECG	24h post procedure

Secondary Outcomes

Measure	Description	Time Frame
Freedom from ventricular arrhythmias	No documentation of sustained ventricular tachycardia or ventricular fibrillation	12 months post-procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Brugada syndrome patients requiring ablation

Exclusion Criteria:

Patients not able to consent

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

Patients with Brugada syndrome and an episode of ventricular tachycardia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Coracao	Recruiting	São Paulo			Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Patient data will be anonymised

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053840	Brugada Syndrome

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided