Trial Outcomes & Findings for Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF (NCT NCT03064451)

Results Overview

Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation \[PVI\] and without cardioversion).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Up to 7 days

Results posted on

2020-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Persistent Atrial Fibrillation (PsAF) Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Overall Study STARTED	60
Overall Study Safety Population	52
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Persistent Atrial Fibrillation (PsAF) Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Overall Study Lost to Follow-up	1
Overall Study Mapping Failure	4
Overall Study Exited prior to procedure	8
Overall Study Withdrew consent: 3-month FU visit	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=60 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Age, Continuous	61.6 Years STANDARD_DEVIATION 9.99 • n=60 Participants
Sex: Female, Male Female	9 Participants n=60 Participants
Sex: Female, Male Male	51 Participants n=60 Participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed.

Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation \[PVI\] and without cardioversion).

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=48 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion).	22.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed.

Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CFGA and PVI without Cardioversion.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=48 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion	33.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed.

Procedural success defined as the conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia after overall ablation procedure, with or without the need for cardioversion.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=48 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Percentage of Participants With Procedural Success	97.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Evaluable population:enrolled participants who had RHYTHMFINDER 192 Catheter inserted, where CFGA performed. 'N' (Number of participants analyzed):number of participants who completed 12 months follow-up(post initial ablation) or data collected from ElectroCardioGram, HM, or Post Procedure Arrhythmia Log forms beyond 337 days post index procedure.

Documented AF/AT/AFL recurrence is defined as any occurrence of documented (symptomatic) atrial fibrillation, atrial flutter, and atrial tachycardia episodes \>= 30 seconds during the post-blanking period (Day 91-365). Here 'HM' signifies Holter monitoring.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=47 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Percentage of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, and Atrial Tachycardia Episodes of Greater Than or Equal to (>=) 30 Seconds to Measure the Effectiveness Success Rate for up to 12 Months	72.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.

Incidence of early-onset (within 7 days of the initial mapping and ablation procedure) Primary Adverse Events (PAEs) was reported. PAEs included death, Atria-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Pericarditis and Major Vascular Access Complication/Bleeding.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Number of Participants With Early-onset Primary Adverse Events Cardiac tamponade / Perforation	2 Participants
Number of Participants With Early-onset Primary Adverse Events Major vascular access complications / bleeding	2 Participants
Number of Participants With Early-onset Primary Adverse Events Pericarditis	1 Participants
Number of Participants With Early-onset Primary Adverse Events Atrio-Esophageal Fistula	0 Participants
Number of Participants With Early-onset Primary Adverse Events Death	0 Participants
Number of Participants With Early-onset Primary Adverse Events Diaphragmatic Paralysis	0 Participants
Number of Participants With Early-onset Primary Adverse Events Heart Block	0 Participants
Number of Participants With Early-onset Primary Adverse Events Myocardial Infarction	0 Participants
Number of Participants With Early-onset Primary Adverse Events Pneumothorax	0 Participants
Number of Participants With Early-onset Primary Adverse Events Pulmonary Edema (Respiratory Insufficiency)	0 Participants
Number of Participants With Early-onset Primary Adverse Events Pulmonary Vein Stenosis	0 Participants
Number of Participants With Early-onset Primary Adverse Events Stroke / Cerebrovascular Accident	0 Participants
Number of Participants With Early-onset Primary Adverse Events Thromboembolism	0 Participants
Number of Participants With Early-onset Primary Adverse Events Transient Ischemic Attack	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed. Here 'N' number of participants analyzed included participants with adenosine/isoproterenol challenge and non-missing confirmation of entry block data collected from the PVI form.

Number of participants with confirmed entrance block after adenosine/isoproterenol challenge was reported.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=16 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge	15 Participants

SECONDARY outcome

Timeframe: Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days)

Population: Evaluable participant included all enrolled participants who had RHYTHMFINDER 192 Catheter inserted, where CARTOFINDER-guided ablation was performed. Here 'n' (number analyzed) included participants analyzed at specified categories for post-CFGA and post PVI.

Change of intra-cycle length from pre-CFGA to post-CFGA and post-PVI is reported to measure the slowing for the overall Atrial Fibrillation rate in both atrium's.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=48 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI Left Atrium: Change post-CFGA	64.0 milliseconds Standard Deviation 273.62
Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI Left Atrium: Change post-PVI	464.0 milliseconds Standard Deviation 1009.44
Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI Right Atrium: Change post-CFGA	33.3 milliseconds Standard Deviation 103.58
Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI Right Atrium: Change post-PVI	525.2 milliseconds Standard Deviation 1120.70

SECONDARY outcome

Timeframe: Up to 12 months

Population: The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.

Any serious adverse event which was related to the device and/or the procedure was defined as a SADE.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months	6 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.

Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months	10 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.

Number of participants with adverse device effects was reported. Adverse Device Effect (ADE's) are adverse events related to the use of an investigational medical device. This definition includes adverse events resulting from insufficient or inadequate instructions for use deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This definition includes any event resulting from use errors or from intentional misuse of the investigational medical device.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Number of Participants With Adverse Device Effects (ADEs) up to 12 Months	20 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Outcome measures

Outcome measures
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 Participants Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events Serious Adverse event	6 Participants
Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events Adverse event	14 Participants

Adverse Events

Participants With Persistent Atrial Fibrillation (PsAF)

Serious events: 10 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 participants at risk Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Cardiac disorders Cardiac tamponade	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Cardiac disorders Pericardial effusion	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Cardiac disorders Pericarditis	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Infections and infestations Infection	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Vascular disorders Arteriovenous fistula	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Vascular disorders Haematoma	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Cardiac disorders Coronary artery occlusion	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Cardiac disorders Atrial fibrillation	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Injury, poisoning and procedural complications Fall	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Injury, poisoning and procedural complications Periprosthetic fracture	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
Musculoskeletal and connective tissue disorders Arthropathy	1.9% 1/52 • Number of events 1 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.

Other adverse events

Other adverse events
Measure	Participants With Persistent Atrial Fibrillation (PsAF) n=52 participants at risk Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure.
Vascular disorders Haematoma	11.5% 6/52 • Number of events 6 • Up to 12 months The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.

Additional Information

Nathalie Macours / Clinical Research Director

Johnson and Johnson Medical NV/SA

Phone: +32 2 746 35 27

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER