Last reviewed · How we verify
AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
NA trial testing AcQMap Imaging and Mapping System in Recurrent Atrial Fibrillation in 128 participants. Completed in 29 October 2020.
| Lead sponsor | Acutus Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 128 |
| Start date | 12 April 2018 |
| Primary completion | 29 October 2020 |
| Estimated completion | 29 October 2020 |
| Sites | 15 locations across Netherlands, Belgium, United Kingdom, Germany, Canada, Czechia |
Acutus Medical
18 and older, any sex, with Recurrent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| AcQMap Imaging and Mapping | 99 |
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
| Group | Value | 95% CI |
|---|---|---|
| AcQMap Arm | 85 |
Documentation of procedure data including total time
| Group | Value | 95% CI |
|---|---|---|
| Subjects Completing the AcQMap Procedure | 3.3 | ± 0.8 |
Documentation of procedure data including fluoroscopy time
| Group | Value | 95% CI |
|---|---|---|
| Subjects Completing the AcQMap Procedure | 25.6 | ± 12.5 |
Documentation of procedure data including ablation times for PVI
| Group | Value | 95% CI |
|---|---|---|
| Subject Who Completed the AcQMap Procedure Receiving Pulmonary Vein Ablations | 8.5 | ± 6.8 |
Documentation of procedure data including ablation times for non-PV targets
| Group | Value | 95% CI |
|---|---|---|
| Subjects Completing the AcQMap Procedure and Receiving Ablations for Non-PV Triggers | 26.2 | ± 19.3 |
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
| Group | Value | 95% CI |
|---|---|---|
| AcQMap Arm | 78 |
Time frame: 24-hours post procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | AcQMap Imaging and Mapping |
|---|---|---|
| Tamponade | Cardiac disorders | — |
| Urine infection | Renal and urinary disorders | — |
| Gallstone | Hepatobiliary disorders | — |
| Arteriovenous fistula | Vascular disorders | — |
| Atrial groin bleeding | Injury, poisoning and procedural complications | — |
| Pericarditis | Cardiac disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| ST-Elevation V1-V3 | Cardiac disorders | — |
| Fever | General disorders | — |
| Aneurysm | Vascular disorders | — |
| Recurrence of atrial fibrillation | Cardiac disorders | — |
| Reaction | System | AcQMap Imaging and Mapping |
|---|---|---|
| groin hematoma | Vascular disorders | — |
| Right groin bleed | Vascular disorders | — |
| Haematurie | Renal and urinary disorders | — |
| Groin pain | Musculoskeletal and connective tissue disorders | — |
| Pericarditis | Cardiac disorders | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| nausea | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Skin Burn | Skin and subcutaneous tissue disorders | — |
| Suspicion neurological event post procedure | Nervous system disorders | — |
Most-reported serious reactions: Tamponade, Urine infection, Gallstone, Arteriovenous fistula, Atrial groin bleeding, Pericarditis, Pericardial effusion, ST-Elevation V1-V3.
Data from ClinicalTrials.gov NCT03368781 adverse events section.
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 \[Canada\])
5 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03368781.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing