Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— UNCOVER-AF  

Official title:

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462980
• Other study ID #: CL-AF-001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 19, 2018

Study information

• Verified date: June 2018
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of the AcQMap High Resolution Mapping and Imaging System to map persistent atrial fibrillation to identify potential mechanistic targets for ablation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 19, 2018
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria (patients must):

1. Be scheduled for ablation of persistent atrial fibrillation due to the arrhythmia being recurrent, poorly tolerated and/or unable to be controlled with at least one antiarrhythmic drug therapy. Persistent atrial fibrillation in this study is defined as the following:

1. AF lasting at least 7 days but no more than 12 months without cardioversion

Or

2. AF lasting at least 48 hours but no more than 12 months prior to cardioversion to terminate AF

2. Be able and willing to give informed consent

Exclusion Criteria (patients must not):

1. Have a history of AF longer than 12 months

2. Have any of the following:

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

2. Patients with implanted pacemaker or ICD

3. Patients with history of embolism or an inability to tolerate anticoagulation therapy during and after an electrophysiology procedure

4. Stents in the area of the pulmonary veins

3. Have a contraindication for transfemoral venous access or any other element of an AF ablation procedure

4. Have a contraindication for transseptal left atrial access including atrial septal occluder device

5. Have a left atrial appendage occlusion device

6. Have had prior ablation for atrial fibrillation

7. NYHA class IV congestive heart failure

8. Left ventricular ejection fraction (LVEF) < 40%

9. Have or have had rheumatic mitral valve disease

10. Have a left atrial diameter of >55 mm (any dimension)

11. Have had a myocardial infarction within the prior three months

12. Have had any atrial surgery (including valve repair/replacement) in the right or left atrium

13. Have an intracardiac thrombus (must be confirmed via ultrasound prior to mapping) or dense spontaneous echo contrast

14. Have clinically significant severe tricuspid and/or mitral valve regurgitation or moderate or severe tricuspid and/or mitral valve stenosis

15. Have had any prior stroke or transient ischemic attacks (TIA) or systemic embolism

16. Be pregnant or nursing

17. Have a life expectancy of less than one year

18. Be currently enrolled in any other clinical treatment study

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Mapping and Ablation
ablation of atrial fibrillation

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Complications	death, stroke/TIA, systemic embolism, cardiac tamponade or pericardial effusion requiring intervention, damage to heart valves requiring intervention, and major groin bleeding requiring transfusion or intervention	30 days
Secondary	Procedural effectiveness	incidence of termination of AF during the procedure without cardioversion	Intraprocedural
Secondary	Clinical effectiveness	Freedom from any adjudicated atrial tachyarrhythmia lasting 30 seconds or more (excluding 3-month stabilization period); on antiarrhythmic drugs; off antiarrhythmic drugs; after a single procedure; after multiple procedures	6 months
Secondary	Clinical effectiveness	Freedom from any adjudicated atrial tachyarrhythmia lasting 30 seconds or more (excluding 3-month stabilization period); on antiarrhythmic drugs; off antiarrhythmic drugs; after a single procedure; after multiple procedures	12 months
Secondary	Clinical effectiveness	Freedom from any adjudicated atrial fibrillation lasting 30 seconds or more(excluding 3-month stabilization period); on antiarrhythmic drugs; off antiarrhythmic drugs; after a single procedure; after multiple procedures	12 months
Secondary	Clinical/partial success	75% or greater reduction in the number of AF episodes, the duration of AF episodes, or the % time a patient is in AF as assessed by 7-day Holter monitoring in the presence or absence of previously ineffective antiarrhythmic drug therapy	12 months
Secondary	Short-term adverse events	Device-and procedure-related adverse events	30 days
Secondary	Long-term Major Complications	death, stroke/TIA, systemic embolism, cardiac tamponade or pericardial effusion requiring intervention, damage to heart valves requiring intervention, and major groin bleeding requiring transfusion or intervention	12 months