NCT01914575

Brief Summary

Use of dipole density mapping to identify activation in complex supraventricular tachycardias

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 31, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 22, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2016

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

July 31, 2013

Last Update Submit

January 29, 2019

Conditions

Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

  • The number of patients with device-related complications

    7 days

  • The number of patients for which activation maps can be created

    7 days

Study Arms (1)

Dipole Density Mapping

EXPERIMENTAL
Device: Mapping with the Acutus Medical System followed by Ablation

Interventions

Mapping with the Acutus Medical System followed by AblationDEVICE
Dipole Density Mapping

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 to 75 years
  • scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
  • able and willing to give informed consent

You may not qualify if:

  • implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
  • myocardial infarction within the prior two months
  • cardiac surgery within the prior three months
  • intracardiac thrombus
  • clinically significant tricuspid valve regurgitation or stenosis
  • any cerebral ischemic event in the prior six months
  • pregnant or nursing
  • currently enrolled in any other clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's University Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Keane, MD

    St Vincent's University Hospital, Ireland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

January 22, 2014

Primary Completion

May 16, 2016

Study Completion

May 16, 2016

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)