| ID | Type | Description | Link |
|---|---|---|---|
| CLP-21-EU | Other Identifier | Acutus Medical, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-randomized | Experimental | All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcQBlate® Force Sensing Ablation System | Device | Percutaneous catheter ablation of the cavotricuspid isthmus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs) | Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs) | 7 days |
| Subjects Achieving Acute Procedural Success | 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. | 20 minutes post ablation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Cardiovascular Research Center | Phoenix | Arizona | 85016 | United States | ||
| Arrhythmia Research Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subject classification:
Screen Failure: exclusion criteria identified. Enrolled: study eligible by meeting all the inclusion and none of the exclusion criteria, up to the point of the procedure (defined as the AcQBlate® FORCE inserted into the body).
Attempted: the AcQBlate® FORCE was inserted into the body and not used for RF ablation.
Treated: the AcQBlate® FORCE was inserted into the body and used for RF ablation.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System. AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Mar 15, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| John Muir Health | Concord | California | 94520 | United States |
| San Diego Cardiac Center Medical Group, Inc. | San Diego | California | 92123 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| BayCare Heath | Clearwater | Florida | 33756 | United States |
| Celebration Hospital | Orlando | Florida | 32803 | United States |
| Bayfront Health | St. Petersburg | Florida | 33701 | United States |
| St Alphonsus Health System | Boise | Idaho | 83704 | United States |
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States |
| Baptist Lexington Medical Center | Lexington | Kentucky | 40503 | United States |
| MedStar Health Research Institute | Hyattsville | Maryland | 80784 | United States |
| Adventist Healthcare | White Oak Medical Center | Silver Spring | Maryland | 20904 | United States |
| Adventist Healthcare, Inc | Silver Spring | Maryland | 20904 | United States |
| Weill Cornell | New York | New York | 10021 | United States |
| Ohio State Med Ctr | Columbus | Ohio | 43201 | United States |
| ProMedica Physician Cardiology | Toledo | Ohio | 43615 | United States |
| Penn State Health | Hershey | Pennsylvania | 17033-0850 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17603 | United States |
| Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System. AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs) | Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs) | Posted | Count of Participants | Participants | 7 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Subjects Achieving Acute Procedural Success | 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. | Of the 115 subjects enrolled, 5 were attempted and had the venous access portion of the ablation procedure initiated and the AcQBlate® FORCE was inserted into the body and not used for RF ablation. Of the 110 Treated subjects, one subject was unevaluable (categorized as BDB indeterminant) therefore 109 subjects were included in primary effectiveness endpoint calculations. | Posted | Count of Participants | Participants | 20 minutes post ablation |
|
|
30 days post-procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System. AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus | 0 | 115 | 12 | 115 | 32 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Congestive Heart Failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic left ventricular failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Stephens, Director Clinical Affairs | Acutus Medical | 442-232-6080 | karen.stephens@acutus.com |
| Aug 10, 2023 |
| Prot_SAP_000.pdf |
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
|