Who is sponsoring NCT03733392?

NCT03733392 is sponsored by Abbott Medical Devices.

What drugs are being tested in NCT03733392?

Interventions in NCT03733392: Advisor HD Grid Mapping Catheter, Sensor Enabled.

What condition does NCT03733392 study?

NCT03733392 studies Persistent Atrial Fibrillation, Ventricular Tachycardia.

Is NCT03733392 still recruiting?

NCT03733392 is currently completed. Last updated 16 April 2024.

Are results published for NCT03733392?

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

Last reviewed 2024-04-16 · How we verify

NCT03733392

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

Advisor HD Grid Observational Study

Completed Results posted Last updated 16 April 2024

What this trial tests

trial testing Advisor HD Grid Mapping Catheter, Sensor Enabled in Persistent Atrial Fibrillation in 379 participants. Completed in 27 May 2021.

Timeline

11 January 2019

Primary endpoint
27 May 2021

27 May 2021

Quick facts

Lead sponsor	Abbott Medical Devices
Status	Completed
Study type	OBSERVATIONAL
Enrollment	379
Start date	11 January 2019
Primary completion	27 May 2021
Estimated completion	27 May 2021
Sites	25 locations across France, Denmark, Italy, Netherlands, South Africa, Austria, Germany, Canada

Drugs / interventions tested

Advisor HD Grid Mapping Catheter, Sensor Enabled

Conditions studied

Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Ventricular Tachycardia — all drugs for Ventricular Tachycardia →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Persistent Atrial Fibrillation or Ventricular Tachycardia. 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.

Rate of Subjects With Acute Success Primary · Immediate post procedure

The rate of acute success is defined as the percent of subjects who received HD Grid mapping and RF energy delivery according to label resulting in acute termination of clinical arrhythmia, defined by termination to sinus rhythm (SR) (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt).

Group	Value	95% CI
PersAF Subjects	287
VT Subjects	14

Rate of Subjects With Long-term Success Primary · PersAF (12 months), VT (6-months)

For PersAF, the rate of long-term success rate is defined as the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and a new or increased dose in class I/III antiarrhythmic drug (AAD). For VT, the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 6-month follow-up. T

Freedom from arrhythmia recurrence and new or increased dose of class I/III AAD

Group	Value	95% CI
PersAF Subjects	168
VT Subjects	14

Freedom from arrhythmia recurrence on or off class I/III AAD

Group	Value	95% CI
PersAF Subjects	173
VT Subjects	14

Overall Procedure Time Secondary · During procedure

Overall procedure time is defined as time from initial catheter insertion to final catheter removal.

Group	Value	95% CI
PersAF Subjects	134.3	± 51.3
VT Subjects	174.1	± 54.2
AFL Subjects	171.4	± 60.3

Radiofrequency (RF) Time Secondary · During Procedure

Defined as duration of time RF energy is delivered

Group	Value	95% CI
PersAF Subjects	32.0	± 23.2
VT Subjects	35.1	± 30.5
AFL Subjects	37.6	± 36.8

Fluoroscopy Time Secondary · During Procedure

Defined as total time subject is exposed to fluoroscopy

Group	Value	95% CI
PersAF Subjects	14.5	± 11.3
VT Subjects	31.3	± 17.4
AFL Subjects	13.7	± 10.6

Mapping Time Associated With Mapping Arrhythmia Secondary · During Procedure

Defined as the total mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)

Group	Value	95% CI
Persistent AF	12.8	± 8.8
Atrial Flutter	13.6	± 11.8
Ventricular Tachycardia	20.6	± 15.3
Other	7.3	± 5.6

Number of Mapping Points Collected Secondary · During Procedure

Defined as total number of mapping points collected for the creation of each map.

Group	Value	95% CI
Persistent AF	10150.8	± 8390.4
Atrial Flutter	10533.1	± 11282.8
Ventricular Tachycardia	16496.2	± 17207.5
Other	3902.5	± 4125.0

Number of Used Mapping Points Per Minute Secondary · During Procedure

Defined as the total number of mapping points used divided by the relative mapping time

Group	Value	95% CI
Persistent AF	203.2	± 172.0
Atrial Flutter	170.8	± 157.5
Ventricular Tachycardia	81.9	± 50.7
Other	180.1	± 199.9

Substrate Characteristics Identified Secondary · During Procedure

For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate.

Low Voltage

Group	Value	95% CI
PersAF Subjects	263
VT Subjects	19
AFL Subjects	42

Fibrosis/Scar

Group	Value	95% CI
PersAF Subjects	117
VT Subjects	17
AFL Subjects	34

Focal Impulses

Group	Value	95% CI
PersAF Subjects	8
VT Subjects	0
AFL Subjects	4

Rotors

Group	Value	95% CI
PersAF Subjects	4
VT Subjects	0
AFL Subjects	1

Complex Fractionated Electrograms (CFE)

Group	Value	95% CI
PersAF Subjects	52
VT Subjects	2
AFL Subjects	9

Other

Group	Value	95% CI
PersAF Subjects	48
VT Subjects	4
AFL Subjects	8

Map Type Used to Define Ablation Strategy Secondary · During Procedure

Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.

Peak-to-Peak

Group	Value	95% CI
Persistent AF	322
Atrial Flutter	9
Ventricular Tachycardia	24
Other	12

Local Activation Time (LAT)

Group	Value	95% CI
Persistent AF	47
Atrial Flutter	42
Ventricular Tachycardia	13
Other	19

CFE Mean

Group	Value	95% CI
Persistent AF	32
Atrial Flutter	0
Ventricular Tachycardia	1
Other	0

Fractionation

Group	Value	95% CI
Persistent AF	9
Atrial Flutter	1
Ventricular Tachycardia	0
Other	0

Peak-Negative

Group	Value	95% CI
Persistent AF	3
Atrial Flutter	0
Ventricular Tachycardia	0
Other	0

Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Secondary · During Procedure

Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.

HD Wave Solution compared to standard configuration

Group	Value	95% CI
Persistent AF	187
Atrial Flutter	24
Ventricular Tachycardia	28
Other	10

Differences Identified - Overall

Group	Value	95% CI
Persistent AF	117
Atrial Flutter	12
Ventricular Tachycardia	16
Other	5

Type of Differences - Location of Low Voltage

Group	Value	95% CI
Persistent AF	69
Atrial Flutter	8
Ventricular Tachycardia	5
Other	1

Type of Differences - Surface Area of Low Voltage

Group	Value	95% CI
Persistent AF	70
Atrial Flutter	8
Ventricular Tachycardia	15
Other	0

Type of Differences - Activation time/sequence

Group	Value	95% CI
Persistent AF	4
Atrial Flutter	3
Ventricular Tachycardia	0
Other	4

Type of Differences - Fractionation

Group	Value	95% CI
Persistent AF	33
Atrial Flutter	1
Ventricular Tachycardia	1
Other	0

Type of Differences - Presence of additional diagnostic signals

Group	Value	95% CI
Persistent AF	1
Atrial Flutter	0
Ventricular Tachycardia	0
Other	0

Type of Differences - Other

Group	Value	95% CI
Persistent AF	3
Atrial Flutter	0
Ventricular Tachycardia	1
Other	0

Maneuverability of HD Grid Catheter Secondary · During Procedure

Defined as the ability to maneuver the HD Grid to each specified anatomic location if attempted, the ability to contact cardiac tissue, and the incidence of induced ectopic beats during maneuvering.

Attempted to make contact with cardiac wall

Group	Value	95% CI
PersAF Subjects	333
VT Subjects	20

Sufficient contact all of the time (100%)

Group	Value	95% CI
PersAF Subjects	67
VT Subjects	0

Sufficient contact most of the time (91-99%)

Group	Value	95% CI
PersAF Subjects	233
VT Subjects	5

Sufficient contact some of the time (52-90%)

Group	Value	95% CI
PersAF Subjects	33
VT Subjects	15

Sufficient contact occasionally (11-50%)

Group	Value	95% CI
PersAF Subjects	0
VT Subjects	0

Sufficient contact rarely (0-10%)

Group	Value	95% CI
PersAF Subjects	0
VT Subjects	0

Difficult reaching a specific area of the heart with HD Grid

Group	Value	95% CI
PersAF Subjects	70
VT Subjects	7

Difficulty reaching Left Atrium

Group	Value	95% CI
PersAF Subjects	66
VT Subjects	0

Adverse events — posted to ClinicalTrials.gov

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

PersAF Subjects

Serious: 39/334 (12%)

Deaths: 1/334

VT Subjects

Serious: 11/38 (29%)

Deaths: 0/38

Serious adverse events (30 terms)

Reaction	System	PersAF Subjects	VT Subjects
ARRHYTHMIA NEW	Cardiac disorders	—	—
ARRHYTHMIA PRE-EXISTING	Cardiac disorders	—	—
CARDIAC PERFORATION OR TAMPONADE	Cardiac disorders	—	—
VASCULAR ACCESS COMPLICATIONS	Vascular disorders	—	—
VASCULAR BLEEDING/LOCAL HEMATOMAS/ECCHYMOSIS	Vascular disorders	—	—
PERICARDIAL EFFUSION	Cardiac disorders	—	—
TRANSIENT ISCHEMIC ATTACK (TIA)	General disorders	—	—
CEREBROVASCULAR ACCIDENT/ STROKE	Nervous system disorders	—	—
INCOMPLETE AV, SINUS NODE, OR OTHER HEART BLOCK	Cardiac disorders	—	—
PULMONARY EDEMA	Respiratory, thoracic and mediastinal disorders	—	—
INFECTION	Infections and infestations	—	—
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	—	—
RESPIRATORY COMPROMISE/DECOMPENSATION	Respiratory, thoracic and mediastinal disorders	—	—
THROMBOSIS/THROMBUS	Blood and lymphatic system disorders	—	—
BLEEDING/ANEMIA	Injury, poisoning and procedural complications	—	—
CARDIAC ARREST	Cardiac disorders	—	—
CHEST PAIN/ANGINA (CARDIAC)	Cardiac disorders	—	—
CORONARY ARTERY THROMBOSIS/OCCLUSION	Cardiac disorders	—	—
EMBOLIC EVENT	Vascular disorders	—	—
HEART FAILURE	Cardiac disorders	—	—
HYPERTENSION	Vascular disorders	—	—
HYPOXIA	Respiratory, thoracic and mediastinal disorders	—	—
MYOCARDIAL INFARCTION	Cardiac disorders	—	—
PAIN (NON-CARDIAC)	General disorders	—	—
PALPITATION	Cardiac disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	PersAF Subjects	VT Subjects
HYPOTENSION	Vascular disorders	—	—
ARTERIOVENOUS FISTULA	Vascular disorders	—	—
BLURRED VISION	Eye disorders	—	—
SHORT TERM LAPSES IN MEMORY	Nervous system disorders	—	—
PAIN (NON-CARDIAC)	General disorders	—	—
PERICARDIAL EFFUSION	Cardiac disorders	—	—
SKIN BURNS/DERMATITIS/ERYTHEMA	Skin and subcutaneous tissue disorders	—	—
VASCULAR ACCESS COMPLICATIONS	Vascular disorders	—	—
PAIN (NON-CARDIAC)	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: ARRHYTHMIA NEW, ARRHYTHMIA PRE-EXISTING, CARDIAC PERFORATION OR TAMPONADE, VASCULAR ACCESS COMPLICATIONS, VASCULAR BLEEDING/LOCAL HEMATOMAS/ECCHYMOSIS, PERICARDIAL EFFUSION, TRANSIENT ISCHEMIC ATTACK (TIA), CEREBROVASCULAR ACCIDENT/ STROKE.

Data from ClinicalTrials.gov NCT03733392 adverse events section.

Sponsor's own description

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Solution™ voltage mapping (hereafter called "HD Wave Solution") in subjects with persistent atrial fibrillation (PersAF) or ventricular tachycardia (VT) in real-world clinical settings.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study.
Fiedler L, Roca I, Lorgat F, Lacotte J, et al · · 2023 · cited 5× · PMID 36481832 · DOI 10.1007/s10840-022-01442-3

Verify or expand the search:

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 Abbott Medical Devices trials

Trials by the same sponsor.

NCT07421076 — Grid eXplore Mapping Study · NA · recruiting
NCT07509658 — TriClip Japan Post-Approval Study · recruiting
NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting

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 NCT03733392 (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 Abbott Medical Devices
Last refreshed: 16 April 2024

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/NCT03733392.

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