| ID | Type | Description | Link |
|---|---|---|---|
| CL-SVT-002 | Other Grant/Funding Number | Acutus Medical | |
| CL-SVT-001 | Other Identifier | Acutus Medical | |
| CL-SVT-004 | Other Identifier | Acutus Medical | |
| CL-SVT-006 | Other Identifier | Acutus Medical | |
| CL-SVT-008 | Other Identifier | Acutus Medical |
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Use of dipole density mapping to identify activation in complex supraventricular tachycardias.
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:
NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, & Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)
All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dipole Density Mapping | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dipole Density Mapping with AcQMap followed by ablation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition. | 7 days |
| The Number of Patients for Which Activation Maps Can be Created | The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps. | 1 day |
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Inclusion Criteria
Exclusion Criteria
Have any of the following:
MI within the prior two (2) months
Cardiac surgery within the prior three (3) months
Intracardiac thrombus
Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
Cerebral ischemic event (including TIA) in the prior six (6) months
Pregnant or nursing
Currently enrolled in another clinical investigation
Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)
NOTE: The additional exclusion criteria for CL-SVT-004 were not expected to alter or bias the patient selection for study enrollment. While these criteria would have been assumed by other investigators as a standard of care for safe enrollment in a clinical study, the German EC approval required the additional statements.
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| Name | Affiliation | Role |
|---|---|---|
| Petr Neuzil, MD | Nemocnice Na Homolce | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan AV Cardiologie | Bruges | 8000 | Belgium | |||
| Southlake Regional Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30895945 | Derived | Grace A, Willems S, Meyer C, Verma A, Heck P, Zhu M, Shi X, Chou D, Dang L, Scharf C, Scharf G, Beatty G. High-resolution noncontact charge-density mapping of endocardial activation. JCI Insight. 2019 Mar 21;4(6):e126422. doi: 10.1172/jci.insight.126422. eCollection 2019 Mar 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Subjects | Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dipole Density Mapping | Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs). Follow-up is 7-10 days for non-AF patients (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each patient. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition. | Posted | Count of Participants | Participants | 7 days |
|
Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
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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 | Treated Subjects | Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site Injury | Surgical and medical procedures | Systematic Assessment | Hematoma right groin. Resolved without treatment. Remained in hospital for observation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal ECG | Cardiac disorders | Systematic Assessment | Right bundle branch block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve McQuillan, Sr. Vice President Regulatory, Clinical, & Quality Assurance | Acutus Medical, Inc. | 442232608- | steven.mcquillan@acutus.com |
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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 | Mar 10, 2016 | Apr 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Newmarket |
| Ontario |
| L3Y 2P9 |
| Canada |
| Pontificia Universidad Catolica de Chile | Santiago | Región Metropolitana | Chile |
| Na Homolce Hospital | Prague | 150 30 | Czechia |
| Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf | Hamburg | D - 20246 | Germany |
| Papworth Hospital NHS Foundation Trust | Cambridge | CB23 | United Kingdom |
| Liverpool Heart and Chest Hospital | Liverpool | L14 3PE | United Kingdom |
| Barts Health NHS Trust | Whitechapel | E1 1BB | United Kingdom |
| Death |
|
| 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 |
|
|
|
| Primary | The Number of Patients for Which Activation Maps Can be Created | The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps. | The study population consists of men and women between the ages of 18 - 75 years of age scheduled for an endocardial ablation for a supraventricular tachycardia (SVT) | Posted | Number | participants | 1 day |
|
|
|
| 3 |
| 85 |
| 10 |
| 85 |
| 30 |
| 85 |
|
| Ablation re-do requiring hospitalization | Surgical and medical procedures | Systematic Assessment | Atrial Fibrillation ablation Re-do |
|
| Valve Dysfunction | Surgical and medical procedures | Systematic Assessment | Worsening of mitral valve regurgitation |
|
| Acute renal Insufficiency | Renal and urinary disorders | Systematic Assessment | Patient was hospitalized due to acute renal insufficiency with anuria, hyperkalemia and signs of systemic infection of unknown etiology. |
|
| Carcinomamammae sin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Pt undergone the surgical resection on 18/NOV/2016 and was discharged from hospital on 22-Nov-2016. Recent check confirmed that marker tumors are normal. |
|
| Shortness of Breath | Cardiac disorders | Systematic Assessment | Progressive shortness of breath secondary to noted heart failure |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment | On 09-MAY-2016 the pacemaker was implanted due to poly-arrhythmia symptoms and due to bradycardia. |
|
| Brain Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Patient was experiencing memory loss. The patient was assessed, CT head performed, followed by an MRI of the head. Diagnosis of glioblastoma multiforme |
|
| Death | Cardiac disorders | Systematic Assessment | Cardiac Arrest |
|
| Abnormal Thyroid Function | Endocrine disorders | Systematic Assessment | Post ablation admitted with abnormal thyroid function labs. Amiodarone stopped |
|
| Chest Infection | Infections and infestations | Systematic Assessment | Patient thought to have developed chest infection. Antibiotics started and discharged 18 May 2016 |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Patient went into fast AF rate 160, this lasted 3-4 hours. The event returned, and the patient was treated at another hospital and pacemaker was inserted on the 3rd August 2016 |
|
| Atrial Flutter | Cardiac disorders | Systematic Assessment | Patient presented to emergency room in flutter. He was given 500mcg x 2 Digoxin and this terminated the flutter into AF. He was discharged the following day. |
|
| Abnormal lab value/infection | Infections and infestations | Systematic Assessment | Leukocytosis as noted by changes in lab values. Controlled by primary care Doctor. |
|
| Access site injury | Surgical and medical procedures | Systematic Assessment | groin hematoma |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | AF recurrence with dyspnea and fatigue |
|
| Air embolism/ST change | Surgical and medical procedures | Systematic Assessment | An apparent air embolism from the AcQGuide Sheath caused a brief (1-2 min) change in ST segment that resolved without treatment |
|
| Arm Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Broken neck of the Humerus |
|
| Chest Pain | Cardiac disorders | Systematic Assessment | Patient described retrosternal chest pain. Echocardiogram shows no pericardial effusion. Mild analgesics prescribed |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Rivaroxaban stopped - Apixaban started due to Diarrhea |
|
| Dizziness and Syncope | Cardiac disorders | Systematic Assessment | Then patient complains of feeling frequently dizzy and as though he will pass out. ECG today shows sinus rhythm at 49bpm. No treatment prescribed |
|
| Exertional Dyspnea | Cardiac disorders | Systematic Assessment | Dyspnea on Exertion. Sotolol discontinued |
|
| Groin Hematoma | Surgical and medical procedures | Systematic Assessment | Groin Hematoma |
|
| Hemorrhoid Bleeding | Blood and lymphatic system disorders | Systematic Assessment | Hemorrhage from Hemorrhoid |
|
| Hypertension | Cardiac disorders | Systematic Assessment | Hypertension |
|
| Infection | Infections and infestations | Systematic Assessment | Infection |
|
| Lower Extremity Swelling | General disorders | Systematic Assessment | Swelling of Lower Extremities |
|
| Pericarditis | Cardiac disorders | Systematic Assessment | Patient developed pericarditis 48 hr. post procedure, resolved with NSAIDS. |
|
| Pleuritic Chest pain | Cardiac disorders | Systematic Assessment | Patient suffered pleuritic chest pain post procedure. Negative work up and mild analgesics prescribed. |
|
| Shortness of breath | Cardiac disorders | Systematic Assessment | By 7 days FU, patient mentioned shortness of breath. Negative chest work up. Abnormal labs for thyroid function noted. AAD medication changed |
|
| Stumble/Fall | General disorders | Systematic Assessment | Stumble fall on the street |
|
| Swollen Legs | General disorders | Systematic Assessment | Swollen Legs. Amlodipine discontinued |
|
| Symptomatic Palpitations | Cardiac disorders | Systematic Assessment | Palpitations and extra systolic beats |
|
| Syncope | Cardiac disorders | Systematic Assessment | Syncopal episodes |
|
| Tonsilitis | Endocrine disorders | Systematic Assessment | Tonsilitis |
|
| Vertigo | General disorders | Systematic Assessment | Patient feels dizzy and had a hematoma in the right eye. 24 hours post-procedure diagnosed with recurrent AF |
|
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |