Trial Outcomes & Findings for Esophageal Deviation in Atrial Fibrillation Ablation (NCT NCT03261973)

NCT ID: NCT03261973

Last Updated: 2021-06-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: during Atrial Fibrillation (AF) ablation procedure (intraoperative)
• Results posted on: 2021-06-30

Participant Flow

Participant milestones

Measure	DV8 Esophageal Deviation Tool This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Overall Study STARTED	47
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Age, Continuous	61.9 years STANDARD_DEVIATION 9.1 • n=43 Participants
Sex: Female, Male Female	12 Participants n=43 Participants
Sex: Female, Male Male	31 Participants n=43 Participants

PRIMARY outcome

Timeframe: during Atrial Fibrillation (AF) ablation procedure (intraoperative)

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.	42 Participants

SECONDARY outcome

Timeframe: during AF ablation procedure

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.	9 Participants

SECONDARY outcome

Timeframe: within 1-90 days of the procedure

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Number of Participants Who Experienced Esophageal Laceration	0 Participants

SECONDARY outcome

Timeframe: during AF ablation procedure

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Number of Participants With PV Reconnection Assessed by Adenosine Infusion	10 Participants

SECONDARY outcome

Timeframe: during AF ablation procedure

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Fluoroscopy Time Measured for the Whole Procedure	23.8 minutes Standard Deviation 8.1

SECONDARY outcome

Timeframe: during the AF ablation procedure

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal	212 minutes Standard Deviation 32

SECONDARY outcome

Timeframe: during the AF ablation procedure

Outcome measures

Measure	DV8 Esophageal Deviation Tool n=43 Participants This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery	53.2 minutes Standard Deviation 16.2

Adverse Events

DV8 Esophageal Deviation Tool

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DV8 Esophageal Deviation Tool n=43 participants at risk This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Gastrointestinal disorders Gastroparesis	2.3% 1/43 • The duration of the study was 3 months
Cardiac disorders Pericarditis	2.3% 1/43 • The duration of the study was 3 months

Additional Information

Grace Ha

Massachusetts General Hospital

Phone: 617-643-1697

Email: gha2@mgh.harvard.edu

Results disclosure agreements

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