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

Atrial Flutter Clinical Trial

— DDRAMATIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872052
• Other study ID #: CL-AFL-001
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: March 6, 2017
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2017
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients in which offline construction of pre- and post-treatment activation maps can be completed	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.	3 months post-procedure
Primary	The number of patients that experience a device-related adverse events as a measure of safety and tolerability		7 days post-procedure