NCT03435393

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 9, 2018

Last Update Submit

February 15, 2018

Conditions

Brugada Syndrome

Outcome Measures

Primary Outcomes (1)

  • Eradication of Brugada syndrome pattern

    Disappearance of type 1 Brugada pattern on post-procedure ECG

    24h post procedure

Secondary Outcomes (1)

  • Freedom from ventricular arrhythmias

    12 months post-procedure

Interventions

Catheter ablationPROCEDURE

Mapping of the epicardium and ablating areas of long fractionated potentials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Brugada syndrome and an episode of ventricular tachycardia

You may qualify if:

  • Brugada syndrome patients requiring ablation

You may not qualify if:

  • Patients not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Instituto do Coracao

São Paulo, Brazil

RECRUITING

Hospital de Santa Cruz

Lisbon, Portugal

RECRUITING

St Bartholomew's Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Consultant, MD PhD

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 19, 2018

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Patient data will be anonymised

Locations

BR(1)PT(1)GB(1)