Atrial FibrillationNCT00584922
Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Endoscopy in group I (all patients)
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2006to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation
Who may be able to join
- 18-80 years
- Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.
Who cannot join
- Contraindication to endoscopy
- Pregnancy
- Prisoners
- Inability or unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1
- Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula
- 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Endoscopy in group I (all patients)
- Keywords
- Esophageal injury, Catheter Ablation, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy in group I (all patients)Procedure or surgery
Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AF ablation group | Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Receives: Procedure: Endoscopy in group I (all patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Esophageal Injury as Assessed by Endoscopy
Endoscopy results and clinical status at one month after endoscopy procedure.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study start5 Dec 2006
- Primary completion11 Mar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Beckman, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584922
- Sponsor's protocol ID
- 13165
- Status last verified
- May 2019
- First submitted
- 20 Dec 2007
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00584922
- Acronym / sponsor ID
- 13165
- Conditions
- Atrial Fibrillation
- Keywords
- Esophageal injury, Catheter Ablation, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 5 Dec 2006 (actual)
- Primary completion
- 11 Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1
- Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF ablation group | – | Procedure: Endoscopy in group I (all patients)Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation
Key inclusion criteria (2 listed)
- 18-80 years
- Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.
Key exclusion criteria (4 listed)
- Contraindication to endoscopy
- Pregnancy
- Prisoners
- Inability or unwillingness to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy in group I (all patients)Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks. | Procedure or surgery | AF ablation group |
Primary outcome
Incidence of Esophageal Injury as Assessed by Endoscopy
Time frame: 1 month
Endoscopy results and clinical status at one month after endoscopy procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Beckman, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Esophageal Injury as Assessed by Endoscopy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.