Recurrent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
Brief summary
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-004 \[EU\]) A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-005 \[Canada\])
Detailed 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 High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-004 \[EU\]) A prospective, single-arm, multi-center, multi-national, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-005 \[Canada\])
Interventions
DEVICEAcQMap Imaging and Mapping System
3D Cardiac Imaging and Mapping during ablation procedures
Sponsors
Acutus Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
None randomized, single-arm, open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female eighteen (18) years of age or older * Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed ≤ twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF
Exclusion criteria
* No more than two (2) previous left-atrial ablations * Structural heart disease or implanted cardiac devices * History of blood clotting or bleeding disease * Pregnant or lactating (current or anticipated during study follow up) * Evidence of left atrial thrombus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets | 12 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out | 4 hours | Documentation of procedure data including total time |
| Procedure Performance: Total Fluoroscopy Time | 4 hours | Documentation of procedure data including fluoroscopy time |
| Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure | 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 |
| Procedure Performance: Ablation Times for Non-PV Targets | 2 hours | Documentation of procedure data including ablation times for non-PV targets |
| Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure | 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 |
| Procedure Performance: Ablation Times for PVI | 2 hours | Documentation of procedure data including ablation times for PVI |
Countries
Belgium, Canada, Czechia, Germany, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | AcQMap Imaging and Mapping |
|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 104 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 11 / 128 |
| serious Total, serious adverse events | 10 / 128 |
Outcome results
Primary
Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AcQMap Imaging and Mapping | Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets | 99 Participants |
Secondary
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure
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
Time frame: 12 months
Population: Subjects who completed a continuous ECG recording at 12-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AcQMap Imaging and Mapping | Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure | 78 Participants |
Secondary
Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure
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
Time frame: 6 months
Population: Subjects who completed a continuous ECG recording at 6-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AcQMap Imaging and Mapping | Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure | 85 Participants |
Secondary
Procedure Performance: Ablation Times for Non-PV Targets
Documentation of procedure data including ablation times for non-PV targets
Time frame: 2 hours
Population: Total RF ablation time for non-PV triggers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcQMap Imaging and Mapping | Procedure Performance: Ablation Times for Non-PV Targets | 26.2 minutes | Standard Deviation 19.3 |
Secondary
Procedure Performance: Ablation Times for PVI
Documentation of procedure data including ablation times for PVI
Time frame: 2 hours
Population: Total RF ablation time for pulmonary vein isolation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcQMap Imaging and Mapping | Procedure Performance: Ablation Times for PVI | 8.5 minutes | Standard Deviation 6.8 |
Secondary
Procedure Performance: Total Fluoroscopy Time
Documentation of procedure data including fluoroscopy time
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcQMap Imaging and Mapping | Procedure Performance: Total Fluoroscopy Time | 25.6 minutes | Standard Deviation 12.5 |
Secondary
Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out
Documentation of procedure data including total time
Time frame: 4 hours
Population: Total procedure time defined as first venous access to last cardiac catheter out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcQMap Imaging and Mapping | Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out | 3.3 hours | Standard Deviation 0.8 |