Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter

Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.

Completed

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan

Bruges, 8000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18-75 years
One documented occurrence of typical AFL within the past 6 months
Be able and willing to sign informed consent

Exclusion criteria

Contraindication to a non-emergent interventional EP procedure
Require treatment in or access to left atrium
Had a myocardial infarction within the prior two months
Had cardiac surgery within the prior three months
Intracardiac thrombus
Permanent pacemaker/ICD leads in/through right atrium
Clinically significant tricuspid valve regurgitation or stenosis
Cerebral ischemic event (including TIA) in the prior six months
Pregnant
Currently enrolled in any other clinical investigation
Any other significant uncontrolled or unstable medical condition

Treatment and study plan

Acutus Medical System Mapping

Device

Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter

Primary outcomes

The number of patients in which offline construction of pre- and post-treatment activation maps can be completed

Time frame: 3 months post-procedure

Proprietary software algorithms will be used generate electrical activation maps based dipole density data acquired by the Acutus Medical Catheter during the procedures. These activation maps will then be applied to a 3D model of the endocardial surface to create a 3D activation map.
The number of patients that experience a device-related adverse events as a measure of safety and tolerability

Time frame: 7 days post-procedure

Sponsors and collaborators

Lead sponsor

Acutus Medical

Industry

Registry information

Acronym: DDRAMATIC

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 7, 2013
Registry last updated: Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed