Atrial Fibrillation
Conditions
Keywords
Esophageal injury, Catheter Ablation, Atrial Fibrillation
Brief summary
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.
Detailed description
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for GI symptoms. Specific Aims: The specific aims of the study are to: 1. Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1 2. Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula 3. Identify predictors of esophageal injury. In particular, to assess if esophageal temperature rises during ablation correlate with development of esophageal injury and if the absence of esophageal temperature rise during ablation correlate with the absence of esophageal injury.
Interventions
PROCEDUREEndoscopy in group I (all patients)
Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
Sponsors
University of Oklahoma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years * Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.
Exclusion criteria
* Contraindication to endoscopy * Pregnancy * Prisoners * Inability or unwillingness to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Esophageal Injury as Assessed by Endoscopy | 1 month | Endoscopy results and clinical status at one month after endoscopy procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 175 |
| Total | 175 |
Baseline characteristics
| Characteristic | AF Ablation Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 131 Participants |
| Region of Enrollment United States | 175 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 171 |
| other Total, other adverse events | 0 / 171 |
| serious Total, serious adverse events | 17 / 171 |
Outcome results
Primary
Incidence of Esophageal Injury as Assessed by Endoscopy
Endoscopy results and clinical status at one month after endoscopy procedure.
Time frame: 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AF Ablation Group | Incidence of Esophageal Injury as Assessed by Endoscopy | Erythema | 1 participants |
| AF Ablation Group | Incidence of Esophageal Injury as Assessed by Endoscopy | Erosion | 12 participants |
| AF Ablation Group | Incidence of Esophageal Injury as Assessed by Endoscopy | Ulcer | 4 participants |
| AF Ablation Group | Incidence of Esophageal Injury as Assessed by Endoscopy | Fistula | 0 participants |
| AF Ablation Group | Incidence of Esophageal Injury as Assessed by Endoscopy | None | 158 participants |