NCT02825992 (UNCOVER-AF) is a NA clinical trial of AcQMap System in Persistent Atrial Fibrillation, sponsored by Acutus Medical.

Who is sponsoring NCT02825992?

NCT02825992 is sponsored by Acutus Medical.

What drugs are being tested in NCT02825992?

Interventions in NCT02825992: AcQMap System.

What condition does NCT02825992 study?

NCT02825992 studies Persistent Atrial Fibrillation.

Is NCT02825992 still recruiting?

NCT02825992 is currently completed. Last updated 5 June 2020.

Are results published for NCT02825992?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-06-05 · How we verify

NCT02825992: UNCOVER-AF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 5 June 2020

What this trial tests

NA trial testing AcQMap System in Persistent Atrial Fibrillation in 129 participants. Completed in 15 May 2018.

Timeline

17 October 2016

Primary endpoint
30 April 2017

15 May 2018

Quick facts

Lead sponsor	Acutus Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	129
Start date	17 October 2016
Primary completion	30 April 2017
Estimated completion	15 May 2018
Sites	12 locations across Italy, Netherlands, United Kingdom, Germany, Canada, Czechia

Drugs / interventions tested

AcQMap System

Conditions studied

Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →

Sponsor

Acutus Medical

Who can join

Adults 18 to 80, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) Primary · 24 hours

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

Group	Value	95% CI
AcQMap System	3
AcQMap System	126

Number of Participants Who Experienced at Least One Adverse Events. Secondary · 12 Months

Recording of all adverse events through 12 month follow-up

ERYTHEMA OF EXTREMITIES

Group	Value	95% CI
AcQMap System	1

BLOOD AND LYMPHATIC SYSTEM DISORDERS

Group	Value	95% CI
AcQMap System	1

CARDIAC DISORDERS

Group	Value	95% CI
AcQMap System	21

CONGENITAL, FAMILIAL AND GENETIC DISORDERS

Group	Value	95% CI
AcQMap System	1

ENDOCRINE DISORDERS

Group	Value	95% CI
AcQMap System	3

EYE DISORDERS

Group	Value	95% CI
AcQMap System	1

GASTROINTESTINAL DISORDERS

Group	Value	95% CI
AcQMap System	8

GENERAL DISORDERS AND ADMIN SITE CONDITIONS

Group	Value	95% CI
AcQMap System	17

Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. Secondary · 24 hours

Conversion to sinus rhythm post ablation

Group	Value	95% CI
AcQMap System	125

Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. Secondary · 6, 9, and 12 Months

Freedom from AF

Group	Value	95% CI
6 Month Off AADs	79
6 Month on AADs	49
9 Months Off AADs	65
9 Months on AADs	36
12 Months Off AADs	84
12 Months on AADs	52

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected through 12 months post-procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AcQMap System

Serious: 33/129 (26%)

Deaths: 0/129

Serious adverse events (37 terms)

Reaction	System	AcQMap System
PNEUMONIA	Infections and infestations	—
ARTERIOVENOUS FISTULA	Vascular disorders	—
ATRIAL FIBRILLATION	Cardiac disorders	—
ATRIAL FLUTTER	Cardiac disorders	—
ATRIAL TACHYCARDIA	Cardiac disorders	—
BRADYCARDIA	Cardiac disorders	—
CARDIAC FAILURE	Cardiac disorders	—
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	—
HYPOTENSION	Vascular disorders	—
ANAEMIA	Blood and lymphatic system disorders	—
CARDIAC TAMPONADE	Cardiac disorders	—
MITRAL VALVE INCOMPETENCE	Cardiac disorders	—
SINUS ARREST	Cardiac disorders	—
SINUS NODE DYSFUNCTION	Cardiac disorders	—
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	—
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	—
VENTRICULAR FIBRILLATION	Cardiac disorders	—
VOMITING	Gastrointestinal disorders	—
CHEST DISCOMFORT	General disorders	—
FATIGUE	General disorders	—
INFLAMMATION	General disorders	—
JAUNDICE	Hepatobiliary disorders	—
ARTERIOGRAM CORONARY	Investigations	—
CATHETERISATION CARDIAC	Investigations	—
EJECTION FRACTION DECREASED	Investigations	—

Other adverse events (66 terms — click to expand)

Reaction	System	AcQMap System
OEDEMA PERIPHERAL	General disorders	—
HAEMATOMA	Vascular disorders	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—
HYPERTHYROIDISM	Endocrine disorders	—
CHEST PAIN	General disorders	—
URINARY TRACT INFECTION	Infections and infestations	—
ANGINA PECTORIS	Cardiac disorders	—
PERICARDIAL EFFUSION	Cardiac disorders	—
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	—
DIZZINESS	Nervous system disorders	—
ARTERIOVENOUS FISTULA	Vascular disorders	—
ADMINISTRATION SITE ERYTHEMA	General disorders	—
ATRIAL FIBRILLATION	Cardiac disorders	—
BRADYCARDIA	Cardiac disorders	—
FATIGUE	General disorders	—
PNEUMONIA	Infections and infestations	—
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	—
HAEMATURIA	Renal and urinary disorders	—
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	—
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	—
INTRACARDIAC THROMBUS	Cardiac disorders	—
PERICARDITIS	Cardiac disorders	—
BLINDNESS TRANSIENT	Eye disorders	—
ABDOMINAL DISTENSION	Gastrointestinal disorders	—
CONSTIPATION	Gastrointestinal disorders	—
DIARRHOEA	Gastrointestinal disorders	—
INGUINAL HERNIA	Gastrointestinal disorders	—
LARGE INTESTINE POLYP	Gastrointestinal disorders	—
NAUSEA	Gastrointestinal disorders	—
OESOPHAGEAL ULCER	Gastrointestinal disorders	—
TOOTH SOCKET HAEMORRHAGE	Gastrointestinal disorders	—
CHILLS	General disorders	—
OEDEMA	General disorders	—
PUNCTURE SITE HAEMORRHAGE	General disorders	—
CHOLELITHIASIS	Hepatobiliary disorders	—
BRONCHITIS	Infections and infestations	—
NASOPHARYNGITIS	Infections and infestations	—
SINUSITIS	Infections and infestations	—
STAPHYLOCOCCAL INFECTION	Infections and infestations	—
CONTUSION	Injury, poisoning and procedural complications	—

Most-reported serious reactions: PNEUMONIA, ARTERIOVENOUS FISTULA, ATRIAL FIBRILLATION, ATRIAL FLUTTER, ATRIAL TACHYCARDIA, BRADYCARDIA, CARDIAC FAILURE, VASCULAR PSEUDOANEURYSM.

Data from ClinicalTrials.gov NCT02825992 adverse events section.

Sponsor's own description

A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ 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 AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial.
Willems S, Verma A, Betts TR, Murray S, et al · · 2019 · cited 82× · PMID 31242746 · DOI 10.1161/circep.119.007233
Charge density mapping demonstrates superiority in catheter ablation of post-surgical atrial tachycardias.
Gagyi RB, Minciuna IA, Bories W, Szili-Torok T. · · 2024 · PMID 39469129 · DOI 10.3389/fcvm.2024.1453273

Verify or expand the search:

Other trials of AcQMap System

Trials testing the same drug.

NCT04431544 — AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US) · terminated
NCT03893331 — AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry) · terminated

Other recruiting trials for Persistent Atrial Fibrillation

Currently open trials in the same condition.

NCT07298473 — Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sp · NA · recruiting
NCT07535268 — REPRESENT-PF Registry · recruiting
NCT07508618 — Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule · Phase 4 · recruiting
NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
NCT07106970 — PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II) · NA · recruiting

Other Acutus Medical trials

Trials by the same sponsor.

NCT04904354 — AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation · NA · withdrawn
NCT04512794 — Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation · NA · withdrawn
NCT05181878 — AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study) · completed
NCT05113056 — AcQForce Pulsed Field Ablation-CE · NA · completed
NCT04658940 — AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02825992 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Acutus Medical
Last refreshed: 5 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02825992.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing