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

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: Completed

Administrative data

• NCT number: NCT03368781
• Other study ID #: CLP-AF-004
• Secondary ID: CLP-AF-005CLP-AF
• Status: Completed
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: October 29, 2020

Study information

• Verified date: July 2022
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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])

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])

Other known NCT identifiers

• NCT03467126

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• 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
• Recurrence
• Recurrent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Brussel Centrum voor Hart-en Vaatziekten	Belsele	Jette
Canada	Southlake Regional Health Center	Newmarket	Ontario
Czechia	Na Homolce Hospital	Prague
Germany	Klinikum Coburg	Coburg
Germany	Klinikum Coburg	Coburg
Germany	Herzzentrum der Universität zu Köln	Cologne
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus MC	Rotterdam
United Kingdom	Papworth Hospital NHS	Cambridge
United Kingdom	Royal Brompton Hospital	London
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Sheffield Teaching Hospital Northern	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Countries where clinical trial is conducted

Belgium,  Canada,  Czechia,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out	Documentation of procedure data including total time	4 hours
Secondary	Procedure Performance: Total Fluoroscopy Time	Documentation of procedure data including fluoroscopy time	4 hours
Secondary	Procedure Performance: Ablation Times for PVI	Documentation of procedure data including ablation times for PVI	2 hours
Secondary	Procedure Performance: Ablation Times for Non-PV Targets	Documentation of procedure data including ablation times for non-PV targets	2 hours
Secondary	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