Trial Outcomes & Findings for Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC) (NCT NCT01520532)

Results Overview

An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Within 1-3 days post ablation

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Ablation Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ablation n=60 Participants
Age, Continuous	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants
Region of Enrollment Belgium	13 participants n=5 Participants
Region of Enrollment Germany	12 participants n=5 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants
Region of Enrollment Italy	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1-3 days post ablation

Population: All subject who underwent an ablation and post-procedure MRI.

An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.

Outcome measures

Outcome measures
Measure	Ablation n=60 Participants
New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.	1 participants

SECONDARY outcome

Timeframe: 30 days

Population: All subjects who underwent an ablation and post-procedure MRI

Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.

Outcome measures

Outcome measures
Measure	Ablation n=60 Participants
Acute Safety Events	1 events

SECONDARY outcome

Timeframe: Day 1 (End of Procedure)

Population: All subjects who underwent ablation and post-procedure MRI.

The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.

Outcome measures

Outcome measures
Measure	Ablation n=60 Participants
Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.	60 participants

Adverse Events

Ablation

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ablation n=60 participants at risk
Vascular disorders Bleeding	1.7% 1/60 • Number of events 1

Other adverse events

Other adverse events
Measure	Ablation n=60 participants at risk
Vascular disorders Groin Bleed	18.3% 11/60 • Number of events 11

Additional Information

Jay Kelley, Director of Clinical Research

Medtronic AF Solutions

Phone: +1.760.827.0076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60