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

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

A prospective, single-arm, multi-center, multi-national, non-randomized, post-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. (CLP-AF-004 [EU])

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. (CLP-AF-005 [Canada])

Study Overview

• Status: Completed
• Conditions: Recurrent Atrial Fibrillation
• Intervention / Treatment: Device: AcQMap Imaging and Mapping System

Detailed Description

A prospective, single-arm, multi-center, multi-national, non-randomized, post-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 includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-004 [EU])

A prospective, single-arm, multi-center, multi-national, 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 includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-005 [Canada])

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Jette
    • Belsele, Jette, Belgium, 1090
      • UZ Brussel Centrum voor Hart-en Vaatziekten
• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Center
• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• Germany
  • Coburg, Germany
    • Klinikum Coburg
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Cologne, Germany, D-50937
    • Herzzentrum der Universität zu Köln
  • Hamburg, Germany, D - 20246
    • Universitatsklinikum Hamburg-Eppendorf
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Hospital
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus MC
• United Kingdom
  • Cambridge, United Kingdom, CB38RE
    • Papworth Hospital NHS
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Middlesbrough, United Kingdom, Ts4 3Bw
    • James Cook University Hospital
  • Newcastle, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospital Northern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: AcQMap Imaging and Mapping; Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.	Device: AcQMap Imaging and Mapping System; 3D Cardiac Imaging and Mapping during ablation procedures; Other Names: AcQMap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure	Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 6-months as measured by a 48-hour continuous ECG	6 months
Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out	Documentation of procedure data including total time	4 hours
Procedure Performance: Total Fluoroscopy Time	Documentation of procedure data including fluoroscopy time	4 hours
Procedure Performance: Ablation Times for PVI	Documentation of procedure data including ablation times for PVI	2 hours
Procedure Performance: Ablation Times for Non-PV Targets	Documentation of procedure data including ablation times for non-PV targets	2 hours
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure	Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 12-months as measured by a 48-hour continuous ECG	12 months

Collaborators and Investigators

• Sponsor: Acutus Medical
• Investigators: Principal Investigator: Andrew Grace, MD, Papworth Hospital NHS

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): October 29, 2020

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: CLP-AF-004; CLP-AF-005 (Other Identifier: Acutus Medical); CLP-AF-004-NL (Other Identifier: Acutus Medical, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes