Trial Outcomes & Findings for Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation (NCT NCT00584922)

Results Overview

Endoscopy results and clinical status at one month after endoscopy procedure.

Recruitment status

COMPLETED

Target enrollment

175 participants

Primary outcome timeframe

1 month

Results posted on

2019-07-15

Participant milestones
Measure	AF Ablation Group Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
Overall Study STARTED	175
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

Baseline characteristics by cohort
Measure	AF Ablation Group n=175 Participants Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	131 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants
Region of Enrollment United States	175 participants n=5 Participants

Timeframe: 1 month

Endoscopy results and clinical status at one month after endoscopy procedure.

Outcome measures
Measure	AF Ablation Group n=175 Participants Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
Incidence of Esophageal Injury as Assessed by Endoscopy Erythema	1 participants
Incidence of Esophageal Injury as Assessed by Endoscopy Erosion	12 participants
Incidence of Esophageal Injury as Assessed by Endoscopy Ulcer	4 participants
Incidence of Esophageal Injury as Assessed by Endoscopy Fistula	0 participants
Incidence of Esophageal Injury as Assessed by Endoscopy None	158 participants

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	AF Ablation Group n=171 participants at risk Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Endoscopy in group I (all patients): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
Gastrointestinal disorders Esophageal erythema	0.58% 1/171 • Number of events 1 • Endoscopy one day after ablation Clinical evaluation 1 month after ablation Adverse events were collected by: 1. endoscopy results 2. Telephone survey at one month
Gastrointestinal disorders Esophageal erosion	7.0% 12/171 • Number of events 12 • Endoscopy one day after ablation Clinical evaluation 1 month after ablation Adverse events were collected by: 1. endoscopy results 2. Telephone survey at one month
Gastrointestinal disorders Esophageal Ulcer	2.3% 4/171 • Number of events 4 • Endoscopy one day after ablation Clinical evaluation 1 month after ablation Adverse events were collected by: 1. endoscopy results 2. Telephone survey at one month

Adverse event data not reported

University of Oklahoma Health Science Center

Phone: 405-271-9696