| ID | Type | Description | Link |
|---|---|---|---|
| CL-AF-001 | Other Identifier | Acutus Medical |
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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 AcQMapâ„¢ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMapâ„¢ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMapâ„¢ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMapâ„¢ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows:
NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)
The above record was combined into one as both protocols are essentially identical (one is post market [EU] and the other pre-market [Canada] and one study report will be written that encompasses the data/results for both protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcQMap System | Other | All patients who underwent catheter ablation using the AcQMap System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcQMap System | Device | 3D imaging and mapping system for cardiac chambers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) | MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Events. | Recording of all adverse events through 12 month follow-up | 12 Months |
| Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Willems, MD | Universitätsklinikum Hamburg-Eppendorf (UKE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlake Regional Health Center | Newmarket | Ontario | L3Y 2P9 | Canada | ||
| Na Homolce Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31242746 | Derived | Willems S, Verma A, Betts TR, Murray S, Neuzil P, Ince H, Steven D, Sultan A, Heck PM, Hall MC, Tondo C, Pison L, Wong T, Boersma LV, Meyer C, Grace A. Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AcQMap System | Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation AcQMap System: 3D imaging and mapping system for cardiac chambers |
| 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 | May 20, 2019 |
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Conversion to sinus rhythm post ablation
| 24 hours |
| Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | Freedom from AF | 6, 9, and 12 Months |
| Prague |
| 150 30 |
| Czechia |
| Vivantes Klinikum Am Urban | Berlin | 10967 | Germany |
| Herzzentrum der Universität zu Köln | Cologne | D-50937 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Centro Cardiologico Monzino | Milan | 20100 | Italy |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| St. Antonius Hospital | Nieuwegein | 3435 CM | Netherlands |
| Freeman Hospital | Newcastle | Newcastle Upon Tyne | NE7 7DN | United Kingdom |
| Papworth Hospital | Cambridge | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AcQMap System | Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation AcQMap System: 3D imaging and mapping system for cardiac chambers |
| 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 Freedom From Device/Procedure Related Major Adverse Events (MAEs) | MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage. | Posted | Count of Participants | Participants | 24 hours |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced at Least One Adverse Events. | Recording of all adverse events through 12 month follow-up | The safety population included all enrolled subjects who had the venous access portion of the ablation procedure initiated. | Posted | Number | participants | 12 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. | Conversion to sinus rhythm post ablation | Number of subjects who had an ablation procedure completed | Posted | Count of Participants | Participants | 24 hours |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | Freedom from AF | Posted | Count of Participants | Participants | 6, 9, and 12 Months |
|
Adverse Events were collected through 12 months 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 System | Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation AcQMap System: 3D imaging and mapping system for cardiac chambers | 0 | 129 | 33 | 129 | 58 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| ARTERIOVENOUS FISTULA | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| SINUS ARREST | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| SINUS NODE DYSFUNCTION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| INFLAMMATION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ARTERIOGRAM CORONARY | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| CATHETERISATION CARDIAC | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
| |
| NEOPLASM RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PULMONARY MASS | Reproductive system and breast disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ABDOMINAL HERNIA REPAIR | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
| |
| LYMPHOCELE | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Congenital, familial and genetic disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ARTERIOVENOUS FISTULA | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| INTRACARDIAC THROMBUS | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| BLINDNESS TRANSIENT | Eye disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| OESOPHAGEAL ULCER | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| TOOTH SOCKET HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ADMINISTRATION SITE ERYTHEMA | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PUNCTURE SITE HAEMORRHAGE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| VASCULAR ACCESS SITE RUPTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| ELECTROCARDIOGRAM ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ATYPICAL FIBROXANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| CARDIAC ABLATION | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
| |
| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
| |
| AIR EMBOLISM | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
| |
| ERYTHEMA OF EXTREMITIES | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
Identified limitations
None of the results, in whole or part, of the study carried out under the study protocol, nor any of the information provided by the sponsor for the purposes of performing the study, were allowed to be published or passed on to any third party without the consent of the sponsor. Any Investigator involved with this study was obligated to provide the sponsor with complete test results and all data derived from the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve McQuillan, Sr. Vice President Regulatory, Clinical, & Quality Assurance | Acutus Medical, Inc. | 763-331-4344 | steven.mcquillan@acutus.com |
| May 15, 2020 |
| 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 |
Not provided
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 |
|
| Czechia |
|
| United Kingdom |
|
| Italy |
|
| Germany |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| ERYTHEMA OF EXTREMITIES |
| |||||
| BLOOD AND LYMPHATIC SYSTEM DISORDERS |
| |||||
| CARDIAC DISORDERS |
| |||||
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS |
| |||||
| ENDOCRINE DISORDERS |
| |||||
| EYE DISORDERS |
| |||||
| GASTROINTESTINAL DISORDERS |
| |||||
| GENERAL DISORDERS AND ADMIN SITE CONDITIONS |
| |||||
| HEPATOBILIARY DISORDERS |
| |||||
| INFECTIONS AND INFESTATIONS |
| |||||
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS |
| |||||
| INVESTIGATIONS |
| |||||
| METABOLISM AND NUTRITION DISORDERS |
| |||||
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS |
| |||||
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED |
| |||||
| NERVOUS SYSTEM DISORDERS |
| |||||
| PSYCHIATRIC DISORDERS |
| |||||
| RENAL AND URINARY DISORDERS |
| |||||
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS |
| |||||
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS |
| |||||
| SURGICAL AND MEDICAL PROCEDURES |
| |||||
| VASCULAR DISORDERS |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| OG005 | 12 Months on AADs | Freedom from AF at 12 Months post ablation on Anti-Arrhythmic Drug (AADs) |
|
|