Trial Outcomes & Findings for Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (NCT NCT02825992)

NCT ID: NCT02825992

Last Updated: 2020-06-05

Results Overview

MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

24 hours

Results posted on

2020-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	129
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	2
Overall Study Procedure terminated	2

Baseline Characteristics

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AcQMap System n=129 Participants 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
Age, Continuous	62.4 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants
Region of Enrollment Netherlands	8 participants n=5 Participants
Region of Enrollment Czechia	11 participants n=5 Participants
Region of Enrollment United Kingdom	54 participants n=5 Participants
Region of Enrollment Italy	6 participants n=5 Participants
Region of Enrollment Germany	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.

Outcome measures

Outcome measures
Measure	AcQMap System n=129 Participants 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	6 Month on AADs Freedom from AF at 6 Months post ablation on Anti-Arrhythmic Drug (AADs)	9 Months Off AADs Freedom from AF at 9 Months post ablation off Anti-Arrhythmic Drug (AADs)	9 Months on AADs Freedom from AF at 9 Months post ablation on Anti-Arrhythmic Drug (AADs)	12 Months Off AADs Freedom from AF at 12 Months post ablation off Anti-Arrhythmic Drug (AADs)	12 Months on AADs Freedom from AF at 12 Months post ablation on Anti-Arrhythmic Drug (AADs)
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) Number of subjects with MAEs	3 Participants	—	—	—	—	—
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) Number of subjects with no MAEs	126 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months

Population: The safety population included all enrolled subjects who had the venous access portion of the ablation procedure initiated.

Recording of all adverse events through 12 month follow-up

Outcome measures

Outcome measures
Measure	AcQMap System n=129 Participants 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	6 Month on AADs Freedom from AF at 6 Months post ablation on Anti-Arrhythmic Drug (AADs)	9 Months Off AADs Freedom from AF at 9 Months post ablation off Anti-Arrhythmic Drug (AADs)	9 Months on AADs Freedom from AF at 9 Months post ablation on Anti-Arrhythmic Drug (AADs)	12 Months Off AADs Freedom from AF at 12 Months post ablation off Anti-Arrhythmic Drug (AADs)	12 Months on AADs Freedom from AF at 12 Months post ablation on Anti-Arrhythmic Drug (AADs)
Number of Participants Who Experienced at Least One Adverse Events. METABOLISM AND NUTRITION DISORDERS	2 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	2 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. INJURY, POISONING AND PROCEDURAL COMPLICATIONS	6 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. INVESTIGATIONS	6 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. ERYTHEMA OF EXTREMITIES	1 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. BLOOD AND LYMPHATIC SYSTEM DISORDERS	1 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. CARDIAC DISORDERS	21 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. CONGENITAL, FAMILIAL AND GENETIC DISORDERS	1 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. ENDOCRINE DISORDERS	3 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. EYE DISORDERS	1 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. GASTROINTESTINAL DISORDERS	8 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. GENERAL DISORDERS AND ADMIN SITE CONDITIONS	17 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. HEPATOBILIARY DISORDERS	2 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. INFECTIONS AND INFESTATIONS	11 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED	4 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. NERVOUS SYSTEM DISORDERS	7 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. PSYCHIATRIC DISORDERS	1 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. RENAL AND URINARY DISORDERS	5 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	10 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. SKIN AND SUBCUTANEOUS TISSUE DISORDERS	1 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. SURGICAL AND MEDICAL PROCEDURES	3 participants	—	—	—	—	—
Number of Participants Who Experienced at Least One Adverse Events. VASCULAR DISORDERS	16 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 hours

Population: Number of subjects who had an ablation procedure completed

Conversion to sinus rhythm post ablation

Outcome measures

Outcome measures
Measure	AcQMap System n=127 Participants 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	6 Month on AADs Freedom from AF at 6 Months post ablation on Anti-Arrhythmic Drug (AADs)	9 Months Off AADs Freedom from AF at 9 Months post ablation off Anti-Arrhythmic Drug (AADs)	9 Months on AADs Freedom from AF at 9 Months post ablation on Anti-Arrhythmic Drug (AADs)	12 Months Off AADs Freedom from AF at 12 Months post ablation off Anti-Arrhythmic Drug (AADs)	12 Months on AADs Freedom from AF at 12 Months post ablation on Anti-Arrhythmic Drug (AADs)
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.	125 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 6, 9, and 12 Months

Freedom from AF

Outcome measures

Outcome measures
Measure	AcQMap System n=112 Participants 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	6 Month on AADs n=112 Participants Freedom from AF at 6 Months post ablation on Anti-Arrhythmic Drug (AADs)	9 Months Off AADs n=88 Participants Freedom from AF at 9 Months post ablation off Anti-Arrhythmic Drug (AADs)	9 Months on AADs n=88 Participants Freedom from AF at 9 Months post ablation on Anti-Arrhythmic Drug (AADs)	12 Months Off AADs n=118 Participants Freedom from AF at 12 Months post ablation off Anti-Arrhythmic Drug (AADs)	12 Months on AADs n=118 Participants Freedom from AF at 12 Months post ablation on Anti-Arrhythmic Drug (AADs)
Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.	79 Participants	49 Participants	65 Participants	36 Participants	84 Participants	52 Participants

Adverse Events

AcQMap System

Serious events: 33 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AcQMap System n=129 participants at risk 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
Cardiac disorders ATRIAL FIBRILLATION	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders ATRIAL FLUTTER	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders ATRIAL TACHYCARDIA	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders BRADYCARDIA	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders CARDIAC FAILURE	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations PNEUMONIA	2.3% 3/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	1.6% 2/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders ARTERIOVENOUS FISTULA	2.3% 3/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders HYPOTENSION	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Blood and lymphatic system disorders ANAEMIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders CARDIAC TAMPONADE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders SINUS ARREST	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders SINUS NODE DYSFUNCTION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders VENTRICULAR FIBRILLATION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders VOMITING	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders CHEST DISCOMFORT	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders FATIGUE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders INFLAMMATION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Hepatobiliary disorders JAUNDICE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Investigations ARTERIOGRAM CORONARY	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Investigations CATHETERISATION CARDIAC	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Investigations EJECTION FRACTION DECREASED	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM RECURRENCE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Nervous system disorders SYNCOPE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Renal and urinary disorders HAEMATURIA	0.78% 1/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
Renal and urinary disorders NEPHROLITHIASIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Renal and urinary disorders URINARY RETENTION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Reproductive system and breast disorders PULMONARY MASS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Surgical and medical procedures ABDOMINAL HERNIA REPAIR	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders LYMPHOCELE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Congenital, familial and genetic disorders PERICARDIAL EFFUSION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.

Other adverse events

Other adverse events
Measure	AcQMap System n=129 participants at risk 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
Cardiac disorders ANGINA PECTORIS	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders ATRIAL FIBRILLATION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders BRADYCARDIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders PERICARDIAL EFFUSION	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Endocrine disorders HYPERTHYROIDISM	2.3% 3/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
General disorders CHEST PAIN	2.3% 3/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
General disorders FATIGUE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders OEDEMA PERIPHERAL	4.7% 6/129 • Number of events 6 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations PNEUMONIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations URINARY TRACT INFECTION	2.3% 3/129 • Number of events 3 • Adverse Events were collected through 12 months post-procedure.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Nervous system disorders DIZZINESS	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Renal and urinary disorders HAEMATURIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	3.9% 5/129 • Number of events 5 • Adverse Events were collected through 12 months post-procedure.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders ARTERIOVENOUS FISTULA	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders HAEMATOMA	4.7% 6/129 • Number of events 6 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders INTRACARDIAC THROMBUS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Cardiac disorders PERICARDITIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Eye disorders BLINDNESS TRANSIENT	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders CONSTIPATION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders DIARRHOEA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders INGUINAL HERNIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders NAUSEA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders OESOPHAGEAL ULCER	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Gastrointestinal disorders TOOTH SOCKET HAEMORRHAGE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders ADMINISTRATION SITE ERYTHEMA	1.6% 2/129 • Number of events 2 • Adverse Events were collected through 12 months post-procedure.
General disorders CHILLS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders OEDEMA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
General disorders PUNCTURE SITE HAEMORRHAGE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Hepatobiliary disorders CHOLELITHIASIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations BRONCHITIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations NASOPHARYNGITIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations SINUSITIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Injury, poisoning and procedural complications CONTUSION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Injury, poisoning and procedural complications FALL	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Injury, poisoning and procedural complications VASCULAR ACCESS SITE RUPTURE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Investigations BLOOD CREATININE INCREASED	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Investigations ELECTROCARDIOGRAM ABNORMAL	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Investigations PROSTATIC SPECIFIC ANTIGEN INCREASED	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Metabolism and nutrition disorders DIABETES MELLITUS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Metabolism and nutrition disorders GOUT	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ATYPICAL FIBROXANTHOMA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Nervous system disorders DYSARTHRIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Nervous system disorders HEADACHE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Nervous system disorders HYPOAESTHESIA	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Psychiatric disorders DEPRESSION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Renal and urinary disorders URINARY RETENTION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Surgical and medical procedures CARDIAC ABLATION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Surgical and medical procedures KNEE ARTHROPLASTY	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders AIR EMBOLISM	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders ARTERIAL OCCLUSIVE DISEASE	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders HYPERTENSION	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Vascular disorders PHLEBITIS	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.
Skin and subcutaneous tissue disorders ERYTHEMA OF EXTREMITIES	0.78% 1/129 • Number of events 1 • Adverse Events were collected through 12 months post-procedure.

Additional Information

Steve McQuillan, Sr. Vice President Regulatory, Clinical, & Quality Assurance

Acutus Medical, Inc.

Phone: 763-331-4344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER