Trial Outcomes & Findings for Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation (NCT NCT01057394)

NCT ID: NCT01057394

Last Updated: 2016-08-01

Results Overview

Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2016-08-01

Participant Flow

The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.

Participant milestones

Measure	Radiofrequency Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation	Visually Guided Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Overall Study STARTED	0	21
Overall Study COMPLETED	0	19
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Radiofrequency Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation	Visually Guided Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Overall Study Not eligible	0	2

Baseline Characteristics

Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation

Baseline characteristics by cohort

Measure	Visually Guided Ablation n=21 Participants Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Age, Continuous	59 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Czech Republic	16 participants n=5 Participants
Region of Enrollment Italy	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.

Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).

Outcome measures

Measure	Number of Chronically Isolated Pulmonary Veins n=17 Participants
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation	46 isolated pulmonary veins

Adverse Events

Visually Guided Ablation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Visually Guided Ablation n=19 participants at risk Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Cardiac disorders Pericardial effusion	5.3% 1/19 • Number of events 1 • Up to 3 months after treatment
Vascular disorders Groin bleed	5.3% 1/19 • Number of events 1 • Up to 3 months after treatment

Other adverse events

Adverse event data not reported

Additional Information

Burke Barrett, VP, Regulatory & Clinical Affairs

CardioFocus, Inc.

Phone: 508 658-7200

Email: bbarrett@cardiofocus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place