Dipole Density Mapping of Typical Atrial 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: NCT01914497
• Other study ID #: CL-AFL-002
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: November 29, 2017
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: November 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: 3
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• Acutus Medical System Mapping

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of device-and procedure-related adverse events		7 days
Primary	The number of patients in which offline construction of pre- and post-treatment activation maps can be completed		7 days