Clinical trial NCT03368781: AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
Official title: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: None randomized, single-arm, open label.
Primary purpose: DIAGNOSTIC

Brief 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 \[Canada\])

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 \[Canada\])

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets
timeFrame: 12 hours
Secondary outcomes:
measure: Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure
timeFrame: 6 months
measure: Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out
timeFrame: 4 hours
measure: Procedure Performance: Total Fluoroscopy Time
timeFrame: 4 hours
measure: Procedure Performance: Ablation Times for PVI
timeFrame: 2 hours
measure: Procedure Performance: Ablation Times for Non-PV Targets
timeFrame: 2 hours
measure: Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Belsele
country: Belgium
facility: UZ Brussel Centrum voor Hart-en Vaatziekten
state: Jette
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Cologne
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital Northern
Study officials:
affiliation: Papworth Hospital NHS
name: Andrew Grace, MD
role: PRINCIPAL_INVESTIGATOR
References: