Trial Outcomes & Findings for Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins. (NCT NCT03437733)

NCT ID: NCT03437733

Last Updated: 2025-06-29

Results Overview

A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: Up to 90 days (post initial mapping and ablation procedure)
• Results posted on: 2025-06-29

Participant Flow

Participant milestones

Measure	Roll-in Study Phase: RF Ablation Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.	Main Study Phase: RF Ablation RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Overall Study STARTED	8	90
Overall Study Safety	8	87
Overall Study COMPLETED	8	87
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Roll-in Study Phase: RF Ablation Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.	Main Study Phase: RF Ablation RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Overall Study Eligibility criteria not met	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Roll-in Study Phase: Radiofrequency (RF) Ablation n=8 Participants Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.	Main Study Phase: RF Ablation n=87 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).	Total n=95 Participants Total of all reporting groups
Age, Continuous	61.9 Years STANDARD_DEVIATION 6.90 • n=8 Participants	60.2 Years STANDARD_DEVIATION 10.05 • n=87 Participants	60.3 Years STANDARD_DEVIATION 9.81 • n=95 Participants
Sex: Female, Male Female	3 Participants n=8 Participants	31 Participants n=87 Participants	34 Participants n=95 Participants
Sex: Female, Male Male	5 Participants n=8 Participants	56 Participants n=87 Participants	61 Participants n=95 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Up to 90 days (post initial mapping and ablation procedure)

Population: The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.

A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=84 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis	0 Participants

PRIMARY outcome

Timeframe: Up to 7 days (post initial mapping and ablation procedure)

Population: The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=84 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding	1 Participants

PRIMARY outcome

Timeframe: Day 1

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Population included participants who had the adenosine/isoproterenol challenge.

Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

Outcome measures

Measure	Radiofrequency (RF) Ablation n=82 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Percentage of Participants With Acute Procedural Success	100 Percentage of participants

SECONDARY outcome

Timeframe: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)

Population: The population analysis included the mITT analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=84 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Individual PAE From Primary Composite Major vascular access complication/bleeding	1 Participants
Number of Participants With Individual PAE From Primary Composite Death	0 Participants
Number of Participants With Individual PAE From Primary Composite Atrio-esophageal fistula	0 Participants
Number of Participants With Individual PAE From Primary Composite Myocardial infraction	0 Participants
Number of Participants With Individual PAE From Primary Composite Cardiac tamponade/perforation	0 Participants
Number of Participants With Individual PAE From Primary Composite Thromboembolism	0 Participants
Number of Participants With Individual PAE From Primary Composite Stroke/cerebrovascular accident (CVA)	0 Participants
Number of Participants With Individual PAE From Primary Composite Transient ischemic attack	0 Participants
Number of Participants With Individual PAE From Primary Composite Phrenic nerve paralysis	0 Participants
Number of Participants With Individual PAE From Primary Composite Pulmonary vein stenosis	0 Participants

SECONDARY outcome

Timeframe: Up to 405 Days

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.

An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=87 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Serious Adverse Device Effects (SADEs)	1 Participants

SECONDARY outcome

Timeframe: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.

Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=87 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure 0 - 7 Days	0 Participants
Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure 8 - 30 Days	0 Participants
Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure >= 31 Days	1 Participants

SECONDARY outcome

Timeframe: Up to 405 Days

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.

An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=87 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Non-serious Adverse Events	46 Participants

SECONDARY outcome

Timeframe: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)

Population: Neurological Assessment Evaluable (NAE) Analysis set was a subset of the Per Protocol Population, consented and were eligible for the required neurological assessments, and had post-ablation MRI. Here 'n' (number analyzed) signifies participants with MRI done at specified time point.

Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=31 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli Pre-procedure	0 Participants
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli Discharge	3 Participants
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli 1 Month	0 Participants
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli Unscheduled visit	0 Participants

SECONDARY outcome

Timeframe: Up to 405 Days

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.

Number of participants with symptomatic and asymptomatic cerebral emboli was reported

Outcome measures

Measure	Radiofrequency (RF) Ablation n=87 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli Symptomatic	0 Participants
Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli Asymptomatic	4 Participants

SECONDARY outcome

Timeframe: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month

Population: Neurological Assessment Evaluable (NAE) Analysis set was a subset of the Per Protocol Population, consented and were eligible for the required neurological assessments, and have post-ablation MRI. Here 'n' (number analyzed) signifies participants with neurological deficit at specified time point.

Number of participants with new or worsening neurologic deficits was reported.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=31 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With New or Worsening Neurologic Deficits Pre-procedure	0 Participants
Number of Participants With New or Worsening Neurologic Deficits Discharge	1 Participants
Number of Participants With New or Worsening Neurologic Deficits 1 Month	0 Participants
Number of Participants With New or Worsening Neurologic Deficits 3 Month	0 Participants
Number of Participants With New or Worsening Neurologic Deficits 6 Month	0 Participants

SECONDARY outcome

Timeframe: Pre-procedure and at discharge (Up to 405 Days)

Population: NAE Analysis set was a subset of the Per Protocol Population, consent and are eligible for the required neurological assessments, and have post-ablation MRI.

The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).

Outcome measures

Measure	Radiofrequency (RF) Ablation n=31 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With NIHSS Scores Pre-procedure: NIHSS Score: 0	31 Participants
Number of Participants With NIHSS Scores Pre-procedure: NIHSS Score: 1-4	0 Participants
Number of Participants With NIHSS Scores Pre-procedure: NIHSS Score: 5-15	0 Participants
Number of Participants With NIHSS Scores Pre-procedure: NIHSS Score: 16-20	0 Participants
Number of Participants With NIHSS Scores Pre-procedure: NIHSS Score: 21-42	0 Participants
Number of Participants With NIHSS Scores Discharge: NIHSS Score: 0	31 Participants
Number of Participants With NIHSS Scores Discharge: NIHSS Score: 1-4	0 Participants
Number of Participants With NIHSS Scores Discharge: NIHSS Score: 5-15	0 Participants
Number of Participants With NIHSS Scores Discharge: NIHSS Score: 16-20	0 Participants
Number of Participants With NIHSS Scores Discharge: NIHSS Score: 21-42	0 Participants

SECONDARY outcome

Timeframe: Up to 405 Days

Population: NAE Analysis set was a subset of the Per Protocol Population, consent and are eligible for the required neurological assessments, and have post-ablation MRI. Here 'n' (number analyzed) signifies participants analyzed at specified time point.

Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=31 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With MoCA Scores Pre-procedure: 0-25	16 Participants
Number of Participants With MoCA Scores Pre-procedure: 26-30	15 Participants
Number of Participants With MoCA Scores 1 Month: 0-25	6 Participants
Number of Participants With MoCA Scores 1 Month: 26-30	24 Participants
Number of Participants With MoCA Scores 3 Month: 0-25	1 Participants
Number of Participants With MoCA Scores 3 Month: 26-30	1 Participants
Number of Participants With MoCA Scores 6 Month: 0-25	1 Participants
Number of Participants With MoCA Scores 6 Month: 26-30	0 Participants

SECONDARY outcome

Timeframe: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.

Hospitalization was defined as prolonged stay greater than or equal to (>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure >= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=87 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Number of Participants With Hospitalization for Cardiovascular Events 0 - 7 Days	2 Participants
Number of Participants With Hospitalization for Cardiovascular Events 8 - 30 Days	0 Participants
Number of Participants With Hospitalization for Cardiovascular Events >= 31 Days	5 Participants

SECONDARY outcome

Timeframe: Up to 405 Days

Population: PP analysis set included participants who were enrolled and met all eligibility criteria; had undergone RF ablation with study catheters; and were treated for the study-related arrhythmia. Here 'n' (number analyzed) signifies number of pulmonary veins (PV) in all evaluable participants analyzed at specified category.

Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=327 PV Veins RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon Catheter Ablation: Left Superior Pulmonary Vein (LSPV)	100.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon Catheter Ablation: Left Inferior Pulmonary Vein (LIPV)	100.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon Catheter Ablation: Right Superior Pulmonary Vein (RSPV)	100.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon Catheter Ablation: Right Inferior Pulmonary Vein (RIPV)	98.8 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon Catheter Ablation: Right Middle Pulmonary Vein (RMPV)	100.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon Catheter Ablation: Left Pulmonary Vein (LPV)-common	100.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon and Focal Catheter Ablation: LSPV	0.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon and Focal Catheter Ablation: LIPV	0.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon and Focal Catheter Ablation: RSPV	0.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon and Focal Catheter Ablation: RIPV	1 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon and Focal Catheter Ablation: RMPV	0.0 Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants Balloon and Focal Catheter Ablation: LPV-common	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 405 Days

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia.

Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=85 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers	3.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to 6 Months

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Percentage of participants with six-month arrythmia recurrence [defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes >30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)] was reported.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=84 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL Documented AF/AT/AFL	76.2 Percentage of participants
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL Documented Symptomatic AF/AT/AFL	81.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode >30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.

Outcome measures

Measure	Radiofrequency (RF) Ablation n=79 Participants RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL Documented AF/AT/AFL	65.8 Percentage of participants
Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL Documented Symptomatic AF/AT/AFL	72.2 Percentage of participants

Adverse Events

Roll-in Study Phase: RF Ablation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Main Study Phase: RF Ablation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Roll-in Study Phase: RF Ablation n=8 participants at risk Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.	Main Study Phase: RF Ablation n=87 participants at risk RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).
Cardiac disorders Major Vascular Access Complication/ Bleeding	0.00% 0/8 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.	1.1% 1/87 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.
Cardiac disorders ST-elevation myocardial infarction	12.5% 1/8 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.	0.00% 0/87 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.
Nervous system disorders Syncope	0.00% 0/8 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.	1.1% 1/87 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/8 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.	1.1% 1/87 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/8 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.	1.1% 1/87 • Up to 405 Days The safety population included all participants who have undergone insertion of the study catheter.

Other adverse events

Adverse event data not reported

Additional Information

Franchise Medical Director

Biosense Webster, Inc.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

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