Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia (DDRAMATIC-SVT)

January 29, 2019 updated by: Acutus Medical

Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • St. Vincent's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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 .
  2. myocardial infarction within the prior two months
  3. cardiac surgery within the prior three months
  4. intracardiac thrombus
  5. clinically significant tricuspid valve regurgitation or stenosis
  6. any cerebral ischemic event in the prior six months
  7. pregnant or nursing
  8. currently enrolled in any other clinical investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dipole Density Mapping
Device: Mapping with the Acutus Medical System followed by Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of patients with device-related complications
Time Frame: 7 days
7 days
The number of patients for which activation maps can be created
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acutus Medical

Investigators

  • Principal Investigator: David Keane, MD, St. Vincent's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 22, 2014

Primary Completion (ACTUAL)

May 16, 2016

Study Completion (ACTUAL)

May 16, 2016

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (ESTIMATE)

August 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-SVT-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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