NCT05508880

Brief Summary

This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 30, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

3.6 years

First QC Date

August 18, 2022

Last Update Submit

August 18, 2022

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures.

    This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.

    2 years

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

At the National Heart Center Singapore, based on national audit data specific for NHCS, approximately 600 ablation procedures are performed per year, of which at least 150 would be expected to suitable for study inclusion. To recruit 40, we would only require \~25% participation rate which we think is realistic.

You may qualify if:

  • Patient undergoing a clinically indicated 3D mapping procedure for a cardiac arrhythmia
  • Ability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lum Luh Nah

CONTACT

6704 2265lum.luh.nah@nhcs.com.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 19, 2022

Study Start

October 30, 2019

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)