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AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
NA trial testing AcQBlate® Force Sensing Ablation System in Typical Atrial Flutter in 115 participants. Completed in 12 June 2022.
| Lead sponsor | Acutus Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 115 |
| Start date | 25 March 2021 |
| Primary completion | 12 May 2022 |
| Estimated completion | 12 June 2022 |
| Sites | 24 locations across Belgium, United Kingdom, United States |
Acutus Medical
18 and older, any sex, with Typical Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
| Group | Value | 95% CI |
|---|---|---|
| All Study Participants | 115 |
Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.
| Group | Value | 95% CI |
|---|---|---|
| All Study Participants | 102 |
Time frame: 30 days post-procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Study Participants |
|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Hypotension | Vascular disorders | — |
| Congestive Heart Failure | Cardiac disorders | — |
| Chronic left ventricular failure | Cardiac disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Pericarditis | Cardiac disorders | — |
| Infection | Infections and infestations | — |
| Deep vein thrombosis | Vascular disorders | — |
| Reaction | System | All Study Participants |
|---|---|---|
| Haematoma | Vascular disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Ecchymosis | Skin and subcutaneous tissue disorders | — |
| Hypertension | Vascular disorders | — |
| Angina pectoris | Cardiac disorders | — |
| Atrial tachycardia | Cardiac disorders | — |
| Pericarditis | Cardiac disorders | — |
| Supraventricular extrasystoles | Cardiac disorders | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Rectal haemorrhage | Gastrointestinal disorders | — |
| Chest discomfort | General disorders | — |
| Hypersensitivity | Immune system disorders | — |
| COVID-19 | Infections and infestations | — |
| Groin abscess | Infections and infestations | — |
| Incision site erythema | Injury, poisoning and procedural complications | — |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Skin burning sensation | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Atrioventricular block second degree, Supraventricular tachycardia, Hypotension, Congestive Heart Failure, Chronic left ventricular failure, Pericardial effusion, Pericarditis, Infection.
Data from ClinicalTrials.gov NCT04658940 adverse events section.
The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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