Trial Outcomes & Findings for Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation (NCT NCT03232645)

Last Updated: 2021-09-05

Results Overview

Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment\* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. \*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

Day 0 and 3 months

Results posted on

2021-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Rhythmia HDx and DirectSense Technology Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Overall Study STARTED	62
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rhythmia HDx and DirectSense Technology n=62 Participants Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter
Age, Continuous	62 years STANDARD_DEVIATION 11 • n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Sex: Female, Male Female	28 Participants n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Sex: Female, Male Male	33 Participants n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Region of Enrollment United Kingdom	19 participants n=62 Participants
Region of Enrollment France	1 participants n=62 Participants
Region of Enrollment Germany	12 participants n=62 Participants
Region of Enrollment Spain	30 participants n=62 Participants
Height	172 cm STANDARD_DEVIATION 9 • n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Weight	80 kg STANDARD_DEVIATION 12 • n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Resting Heart Rate	66 bpm STANDARD_DEVIATION 15 • n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Systolic Blood pressure	126 mmHg STANDARD_DEVIATION 16 • n=61 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline
Diastolic Blood Pressure	72 mmHg STANDARD_DEVIATION 9 • n=60 Participants • 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline. For one additional subject the data was not collected

PRIMARY outcome

Timeframe: Day 0 and 3 months

Population: 51 subjects were included in the analysis as 7 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.

Outcome measures

Outcome measures
Measure	Rhythmia HDx and DirectSense Technology n=3872 Overall number of Ablations Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment Local Impedance change in Pulmonary Veins segments where block was not achieved	-13.9 ohm Interval -21.5 to -8.8
Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment Local Impedance at Baseline in Pulmonary Veins segments where block was achieved	106.2 ohm Interval 96.6 to 117.4
Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved	101.9 ohm Interval 92.8 to 113.9
Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment Local Impedance change in Pulmonary Veins segments where block was achieved	-19.6 ohm Interval -27.5 to -13.0

SECONDARY outcome

Timeframe: Day 0

Population: 55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.

Acute isolation gaps per anatomical segment\* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0). \*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.

Outcome measures

Outcome measures
Measure	Rhythmia HDx and DirectSense Technology n=3750 Overall number of Ablations Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Local Impedance and Local Impedance Change and PVI Gaps at Day Zero Local Impedance at Baseline in Pulmonary Veins segments where block was achieved	107 ohm Interval 97.5 to 118.1
Local Impedance and Local Impedance Change and PVI Gaps at Day Zero Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved	101.1 ohm Interval 92.5 to 112.0
Local Impedance and Local Impedance Change and PVI Gaps at Day Zero Local Impedance change in Pulmonary Veins segments where block was achieved	-19.4 ohm Interval -27.5 to -12.8
Local Impedance and Local Impedance Change and PVI Gaps at Day Zero Local Impedance change in Pulmonary Veins segments where block was not achieved	-10.9 ohm Interval -18.0 to -6.6

SECONDARY outcome

Timeframe: Day 0

At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.

Outcome measures

Outcome measures
Measure	Rhythmia HDx and DirectSense Technology n=60 Participants Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Number of Gaps at Day Zero Number of gaps per Left PV pair after initial encircling	1.4 Number of gaps Standard Deviation 1.6
Number of Gaps at Day Zero Number of gaps per Right PV pair after initial encircling	1.5 Number of gaps Standard Deviation 1.6

SECONDARY outcome

Timeframe: Day 0

Population: 55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.

Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.

Outcome measures

Outcome measures
Measure	Rhythmia HDx and DirectSense Technology n=55 Participants Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Baseline Local Impedance and Local Impedance Change at Day Zero Baseline Local Impedance during initial applications	107.9 ohm Standard Deviation 15.9
Baseline Local Impedance and Local Impedance Change at Day Zero Baseline Local Impedance during touch up applications	96.1 ohm Standard Deviation 13
Baseline Local Impedance and Local Impedance Change at Day Zero Local Impedance change during initial applications	-19.8 ohm Standard Deviation 11.1
Baseline Local Impedance and Local Impedance Change at Day Zero Local Impedance change during touch up applications	-20.2 ohm Standard Deviation 9.5

SECONDARY outcome

Timeframe: Day 0

At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.

Outcome measures

Outcome measures
Measure	Rhythmia HDx and DirectSense Technology n=60 Participants Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Maximum Number of Gaps Per PV Segment at Day Zero Maximum # of gaps observed in a left PV pair segment at index procedure = along appendage/LA ridge	25 Number of gaps
Maximum Number of Gaps Per PV Segment at Day Zero Maximum # of gaps observed in a right PV pair segment at index procedure = near LA roof	18 Number of gaps

SECONDARY outcome

Timeframe: Day 0

Population: 55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.

Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps

Outcome measures

Outcome measures
Measure	Rhythmia HDx and DirectSense Technology n=3750 Overall number of Ablations Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Local Impedance in Segments With Maximum Number of Gaps at Day Zero Average baseline local impedance in left PV segment with maximum gaps = along appendage/LA ridge	105.2 ohm Standard Deviation 13.5
Local Impedance in Segments With Maximum Number of Gaps at Day Zero Average baseline local impedance in right PV segment with maximum gaps = near LA roof	105.1 ohm Standard Deviation 14.3

Adverse Events

Rhythmia HDx and DirectSense Technology

Serious events: 8 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rhythmia HDx and DirectSense Technology n=62 participants at risk Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Surgical and medical procedures Infection	3.2% 2/62 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures Adverse reaction - Neurological (non-TIA, non-stroke)	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures Stroke (ischemic)	3.2% 2/62 • Number of events 2 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Cardiac disorders Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Respiratory, thoracic and mediastinal disorders Pulmonary	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Cardiac disorders Sinus Bradycardia	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.

Other adverse events

Other adverse events
Measure	Rhythmia HDx and DirectSense Technology n=62 participants at risk Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.
Surgical and medical procedures Hemoptosis	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures Left Atrial (type II) Flutter	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures NSVT (Non Sustained Ventricular Tachycardia)	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures Pseudoaneurysm	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures Visual blurring/disturbances	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
Surgical and medical procedures Atrial Flutter, not specified	1.6% 1/62 • Number of events 1 • Adverse events were collected from enrollment to end of follow-up: 4 Months. Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.

Additional Information

Clinical Trial Manager

Boston Scientific

Phone: 00393421994999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place