AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation (RECOVER AF)

Recurrent Atrial Fibrillation Clinical Trial

— RECOVER AF  

Official title:

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03467126
• Other study ID #: CLP-AF-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: May 2020

Study information

• Verified date: November 2018
• Source: Acutus Medical
• Contact: Steven McQuillan, BS
• Phone: 442.232.6080
• Email: steven.mcquillan[@]acutusmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure.

Description:

A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population inlcudes men and women, eighteen (10) years of age or older, who in the past twenty-four (24) months have had no more than two (2) previous left-atrial ablations for AF treatment. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occr at screening, procedure, hospital discharge, 3-, 6-, and 12-months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female eighteen (18) years of age or older

• Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed = twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF

Exclusion Criteria:

• No more than two (2) previous left-atrial ablations

• Structural heart disease or implanted cardiac devices

• History of blood clotting or bleeding disease

• Pregnant or lactating (current or anticipated during study follow up)

• Evidence of left atrial thrombus

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrent Atrial Fibrillation

Intervention

Device:
• AcQMap Imaging and Mapping
3D Cardiac Imagining and Mapping during ablation procedures

Locations

Country	Name	City	State
Canada	Southlake Regional Health Center	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	Acute procedural efficacy	At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap System	12 hours
Secondary	Longer term arrhythmia management	Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 6-, and 12-months as measured by a 48-hour continuous ECG	6 and 12 months
Secondary	Procedure performance	Documentation of procedure data including total time	4 hours
Secondary	Procedure performance	Documentation of procedure data including fluoroscopy time	2 hours
Secondary	Procedure performance	Documentation of procedure data ablation times for PVI	2 hours
Secondary	Procedure performance	Documentation of procedure data ablation times non-PV targets	2 hours