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Completed

NCT Number: NCT03368781

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

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])

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Key information

Conditions

Recurrent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel Centrum voor Hart-en Vaatziekten, Belsele, Jette, Belgium

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About this study

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])

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AcQMap Imaging and Mapping System

Device

3D Cardiac Imaging and Mapping during ablation procedures

Other names: AcQMap

Primary outcomes

  1. Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets

    Time frame: 12 hours

    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

Secondary outcomes

  1. Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure

    Time frame: 6 months

    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

  2. Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out

    Time frame: 4 hours

    Documentation of procedure data including total time

  3. Procedure Performance: Total Fluoroscopy Time

    Time frame: 4 hours

    Documentation of procedure data including fluoroscopy time

  4. Procedure Performance: Ablation Times for PVI

    Time frame: 2 hours

    Documentation of procedure data including ablation times for PVI

  5. Procedure Performance: Ablation Times for Non-PV Targets

    Time frame: 2 hours

    Documentation of procedure data including ablation times for non-PV targets

  6. Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Acutus Medical

Industry

Registry information

Official study title

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

Acronym: RECOVER AF

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2017
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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