Trial Outcomes & Findings for INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation (NCT NCT03372798)

Results Overview

Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = \[(vessel area - lumen area)/vessel area\] x 100

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

Day 1

Results posted on

2024-04-18

Participant Flow

Recruitment performed from November 2016 to October 2017 in Cardiology Outpatient Clinic. A total of 14 patients enrolled. 2 patients had incomplete datasets so 12 patients available for analysis.

Two recruited patients were not included in the data analysis because of * no intravascular ultrasound imaging available due to technical issue in 1 patient; * no post-operative CT scan performed by 1 patient.

Participant milestones

Participant milestones
Measure	Intracardiac Echo (ICE) Imaging Pulmonary vein imaging performed during atrial fibrillation ablation with ICE	Intravascular Ultrasound (IVUS) Imaging Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS
Overall Study STARTED	8	6
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intracardiac Echo (ICE) Imaging Pulmonary vein imaging performed during atrial fibrillation ablation with ICE	Intravascular Ultrasound (IVUS) Imaging Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS
Overall Study Patient not attending post-procedural CT scan	1	0
Overall Study Failure of imaging probe	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intracardiac Echo (ICE) Imaging n=7 Participants Pulmonary vein imaging performed during atrial fibrillation ablation with ICE	Intravascular Ultrasound (IVUS) Imaging n=5 Participants Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS	Total n=12 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=7 Participants	63 years STANDARD_DEVIATION 9 • n=5 Participants	64 years STANDARD_DEVIATION 10 • n=12 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	7 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=12 Participants
Ablation modality for Pulmonary Vein Isolation Radiofrequency energy	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=12 Participants
Ablation modality for Pulmonary Vein Isolation Cryoenergy	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=12 Participants
Ablation modality for Pulmonary Vein Isolation Laser energy	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=12 Participants

PRIMARY outcome

Timeframe: Day 1

Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = \[(vessel area - lumen area)/vessel area\] x 100

Outcome measures

Outcome measures
Measure	Intracardiac Echo (ICE) Imaging n=7 Participants Pulmonary vein imaging performed during atrial fibrillation ablation with ICE	Intravascular Ultrasound (IVUS) Imaging n=5 Participants Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS
Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames Pre-ablation	22.18 percentage Interval 16.4 to 29.1	23.15 percentage Interval 20.8 to 27.8
Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames Post-ablation	27.04 percentage Interval 20.6 to 34.4	27.09 percentage Interval 22.8 to 32.3

PRIMARY outcome

Timeframe: 1 day

Population: The analysis was not possible as the CT images were inadvertently deleted before any analysis was performed.

Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = \[(vessel area - lumen area)/vessel area\] x 100

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Mean time required to image the left atrium for measurement of left atrial wall thickness with intracardiac echo (ICE) or with intravascular ultrasound (IVUS)

Outcome measures

Outcome measures
Measure	Intracardiac Echo (ICE) Imaging n=7 Participants Pulmonary vein imaging performed during atrial fibrillation ablation with ICE	Intravascular Ultrasound (IVUS) Imaging n=5 Participants Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS
Mean Time Required for ICE/IVUS for Real Time Imaging of the Left Atrial (LA) Wall Thickness During AF Ablation	24.8 minutes Standard Deviation 3.4	25 minutes Standard Deviation 3.5

SECONDARY outcome

Timeframe: Day 1

Number of intracardiac echo (ICE) cases and number of intravascular ultrasound (IVUS) cases of good quality, allowing a precise measurement of the left atrial (LA) wall thickness The imaging quality of each PV cross-section was defined as good quality if the vessel contour was visible in all 4 quadrants.

Outcome measures

Outcome measures
Measure	Intracardiac Echo (ICE) Imaging n=28 Pulmonary Vein cross-sections Pulmonary vein imaging performed during atrial fibrillation ablation with ICE	Intravascular Ultrasound (IVUS) Imaging n=20 Pulmonary Vein cross-sections Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS
Number of ICE/IVUS Cases of Good Quality	24 Pulmonary Vein cross-sections	0 Pulmonary Vein cross-sections

Adverse Events

Intracardiac Echo (ICE) Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravascular Ultrasound (IVUS) Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Tim Betts

Oxford University Hospitals NHS Foundation Trust

Phone: 0044 01865 220256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place