Trial Outcomes & Findings for AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation (NCT NCT03368781)

NCT ID: NCT03368781

Last Updated: 2022-07-27

Results Overview

At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap System

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 128 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2022-07-27

Participant Flow

Participant milestones

Measure	AcQMap Imaging and Mapping Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Overall Study STARTED	128
Overall Study Treated Subjects	106
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation

Baseline characteristics by cohort

Measure	AcQMap Imaging and Mapping n=106 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Age, Continuous	63.0 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 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	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	104 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

PRIMARY outcome

Timeframe: 12 hours

Population: Individual vein isolation was not documented in the protocol. Subjects leaving the lab in sinus rhythm was the surrogate for vein isolation.

At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap System

Outcome measures

Measure	AcQMap Imaging and Mapping n=106 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets	99 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Subjects who completed a continuous ECG recording at 6-months

Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 6-months as measured by a 48-hour continuous ECG

Outcome measures

Measure	AcQMap Imaging and Mapping n=100 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure	85 Participants

SECONDARY outcome

Timeframe: 4 hours

Population: Total procedure time defined as first venous access to last cardiac catheter out

Documentation of procedure data including total time

Outcome measures

Measure	AcQMap Imaging and Mapping n=106 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out	3.3 hours Standard Deviation 0.8

SECONDARY outcome

Timeframe: 4 hours

Documentation of procedure data including fluoroscopy time

Outcome measures

Measure	AcQMap Imaging and Mapping n=106 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Procedure Performance: Total Fluoroscopy Time	25.6 minutes Standard Deviation 12.5

SECONDARY outcome

Timeframe: 2 hours

Population: Total RF ablation time for pulmonary vein isolation

Documentation of procedure data including ablation times for PVI

Outcome measures

Measure	AcQMap Imaging and Mapping n=76 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Procedure Performance: Ablation Times for PVI	8.5 minutes Standard Deviation 6.8

SECONDARY outcome

Timeframe: 2 hours

Population: Total RF ablation time for non-PV triggers

Documentation of procedure data including ablation times for non-PV targets

Outcome measures

Measure	AcQMap Imaging and Mapping n=103 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Procedure Performance: Ablation Times for Non-PV Targets	26.2 minutes Standard Deviation 19.3

SECONDARY outcome

Timeframe: 12 months

Population: Subjects who completed a continuous ECG recording at 12-months

Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 12-months as measured by a 48-hour continuous ECG

Outcome measures

Measure	AcQMap Imaging and Mapping n=103 Participants Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure	78 Participants

Adverse Events

AcQMap Imaging and Mapping

Serious events: 10 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	AcQMap Imaging and Mapping n=128 participants at risk Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Cardiac disorders Tamponade	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Renal and urinary disorders Urine infection	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Hepatobiliary disorders Gallstone	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Vascular disorders Arteriovenous fistula	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Injury, poisoning and procedural complications Atrial groin bleeding	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Cardiac disorders Pericarditis	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Cardiac disorders Pericardial effusion	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Cardiac disorders ST-Elevation V1-V3	0.78% 1/128 • Number of events 1 • 24-hours post procedure
General disorders Fever	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Vascular disorders Aneurysm	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Cardiac disorders Recurrence of atrial fibrillation	0.78% 1/128 • Number of events 1 • 24-hours post procedure

Other adverse events

Measure	AcQMap Imaging and Mapping n=128 participants at risk Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. AcQMap Imaging and Mapping System: 3D Cardiac Imaging and Mapping during ablation procedures
Vascular disorders groin hematoma	1.6% 2/128 • Number of events 2 • 24-hours post procedure
Vascular disorders Right groin bleed	1.6% 2/128 • Number of events 2 • 24-hours post procedure
Renal and urinary disorders Haematurie	1.6% 2/128 • Number of events 2 • 24-hours post procedure
Cardiac disorders Pericarditis	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Musculoskeletal and connective tissue disorders Groin pain	1.6% 2/128 • Number of events 2 • 24-hours post procedure
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Gastrointestinal disorders nausea	0.78% 1/128 • Number of events 1 • 24-hours post procedure
General disorders Fever	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Skin and subcutaneous tissue disorders Skin Burn	0.78% 1/128 • Number of events 1 • 24-hours post procedure
Nervous system disorders Suspicion neurological event post procedure	0.78% 1/128 • Number of events 1 • 24-hours post procedure

Additional Information

Steve McQuillan

Acutus Medical, Inc.

Phone: 4422326080

Email: steven.mcquillan@acutus.com

Results disclosure agreements

• Principal investigator is a sponsor employee Restriction of individual site publication until the multi-center data is published
• Publication restrictions are in place

Restriction type: OTHER