Dipole Density Mapping of Typical Atrial Flutter (DDRAMATIC)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Device: Acutus Medical System Mapping

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

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. Be aged 18 to 75 years
2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
3. Be able and willing to give informed consent

Exclusion Criteria:

1. Have any of the following:

   1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.

   1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.

2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
3. Have had a myocardial infarction within the prior two months
4. Have had cardiac surgery within the prior three months
5. Have an intracardiac thrombus
6. Have clinically significant tricuspid valve regurgitation or stenosis
7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
8. Be pregnant or nursing
9. Be currently enrolled in any other clinical investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acutus Medical System; 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.	Device: Acutus Medical System Mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of device-and procedure-related adverse events	7 days
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed	7 days

Collaborators and Investigators

• Sponsor: Acutus Medical
• Investigators: Principal Investigator: Stephan Willems, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

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): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: CL-AFL-002