| ID | Type | Description | Link |
|---|---|---|---|
| CLP-AF-005 | Other Identifier | Acutus Medical | |
| CLP-AF-004-NL | Other Identifier | Acutus Medical, Inc. |
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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])
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])
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcQMap Imaging and Mapping | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcQMap Imaging and Mapping System | Device | 3D Cardiac Imaging and Mapping during ablation procedures |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Grace, MD | Papworth Hospital NHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel Centrum voor Hart-en Vaatziekten | Belsele | Jette | 1090 | Belgium | ||
| Southlake Regional Health Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 |
None randomized, single-arm, open label.
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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 |
| Newmarket |
| Ontario |
| L3Y 2P9 |
| Canada |
| Na Homolce Hospital | Prague | 150 30 | Czechia |
| Klinikum Coburg | Coburg | 96450 | Germany |
| Klinikum Coburg | Coburg | Germany |
| Herzzentrum der Universität zu Köln | Cologne | D-50937 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | D - 20246 | Germany |
| St. Antonius Hospital | Nieuwegein | 3435 CM | Netherlands |
| Erasmus MC | Rotterdam | 3015 CE | Netherlands |
| Papworth Hospital NHS | Cambridge | CB38RE | United Kingdom |
| Royal Brompton Hospital | London | Sw3 6NP | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Freeman Hospital | Newcastle | NE7 7DN | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Sheffield Teaching Hospital Northern | Sheffield | United Kingdom |
| Treated Subjects |
|
| COMPLETED |
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| NOT COMPLETED |
|
Number of subjects treated
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Individual vein isolation was not documented in the protocol. Subjects leaving the lab in sinus rhythm was the surrogate for vein isolation. | Posted | Count of Participants | Participants | No | 12 hours |
|
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| |||||||||||||||||||||||||
| 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 | Subjects who completed a continuous ECG recording at 6-months | Posted | Count of Participants | Participants | 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 | Total procedure time defined as first venous access to last cardiac catheter out | Posted | Mean | Standard Deviation | hours | 4 hours |
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| Secondary | Procedure Performance: Total Fluoroscopy Time | Documentation of procedure data including fluoroscopy time | Posted | Mean | Standard Deviation | minutes | 4 hours |
|
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| ||||||||||||||||||||||||||
| Secondary | Procedure Performance: Ablation Times for PVI | Documentation of procedure data including ablation times for PVI | Total RF ablation time for pulmonary vein isolation | Posted | Mean | Standard Deviation | minutes | 2 hours |
|
| ||||||||||||||||||||||||||
| Secondary | Procedure Performance: Ablation Times for Non-PV Targets | Documentation of procedure data including ablation times for non-PV targets | Total RF ablation time for non-PV triggers | Posted | Mean | Standard Deviation | minutes | 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 | Subjects who completed a continuous ECG recording at 12-months | Posted | Count of Participants | Participants | 12 months |
|
|
24-hours post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures | 0 | 128 | 10 | 128 | 11 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tamponade | Cardiac disorders | Not used | Systematic Assessment |
| |
| Urine infection | Renal and urinary disorders | Not used | Systematic Assessment | Urine infection with urinary retention |
|
| Gallstone | Hepatobiliary disorders | Not used | Systematic Assessment | Gallstone cholecystitis |
|
| Arteriovenous fistula | Vascular disorders | Not used | Systematic Assessment |
| |
| Atrial groin bleeding | Injury, poisoning and procedural complications | Not used | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | Not used | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | Not used | Systematic Assessment |
| |
| ST-Elevation V1-V3 | Cardiac disorders | Not used | Systematic Assessment |
| |
| Fever | General disorders | Not used | Systematic Assessment | Fever after pvi within 48 hours with prolongation |
|
| Aneurysm | Vascular disorders | Not used | Systematic Assessment | Aneurysm spurium right groin |
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| Recurrence of atrial fibrillation | Cardiac disorders | Not used | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| groin hematoma | Vascular disorders | Not used | Systematic Assessment |
| |
| Right groin bleed | Vascular disorders | Not used | Systematic Assessment |
| |
| Haematurie | Renal and urinary disorders | Not used | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | Not used | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | Not used | Systematic Assessment | Bi-lateral and right |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Not used | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | Not used | Systematic Assessment |
| |
| Fever | General disorders | Not used | Systematic Assessment |
| |
| Skin Burn | Skin and subcutaneous tissue disorders | Not used | Systematic Assessment |
| |
| Suspicion neurological event post procedure | Nervous system disorders | Not used | Systematic Assessment |
|
Restriction of individual site publication until the multi-center data is published
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve McQuillan | Acutus Medical, Inc. | 4422326080 | steven.mcquillan@acutus.com |
| Mar 17, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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