Atrial FibrillationNCT03960346
Cryoballoon and Associated Esophageal Effects
A study testing Ablation with cryoenergy in people with Atrial Fibrillation, run by Baylor Research Institute.
Trial summary
The primary objectives are to determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation with cryoenergy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2015to 2 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
- Age >18 years
- Planned AF cryoablation procedure
Who cannot join
- LA diameter >55mm
- Severe LVH (LV wall ≥ 15mm)
- LA thrombus
- Decompensated heart failure
- Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
- History of previous pulmonary vein isolation
Show all 9Show fewer
- Inability to place esophageal temperature probe or TEE probe
- Previously documented phrenic nerve injury
- Known esophageal pathology (complete GI history worksheet)
About this study
Official title: Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)
The primary objectives are to determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively. To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include:
- Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations
- Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations
- Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations As well as to associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
Read the detailed description
When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation with cryoenergy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation with cryoenergyProcedure or surgery
Also called esophageal temperature-guided ablation
Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Effects | Other | To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. Esophageal temperature probe is used during cryoablation to measure temperatures and then a 4-7 days post procedure esophagoscopy is performed to evaluate the physical effects on the esophagus. Receives: Procedure: Ablation with cryoenergy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of temperature decline
Compare the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation using a esotest probe esophageal temperature probe to record the esophageal temperatures
Measured: Up to 3 years
Associate the development of symptoms
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations using a symptom questionnaire and visualize the esophagus 4-7 days post procedure via esophagoscopy
Measured: Up to 3 years
Secondary outcomes (2)
Phrenic nerve injury
To collect data phrenic nerve injury assessed with patient symptom questionnaire
Measured: Up to 3 years
Post procedure symptoms
To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start25 Nov 2015
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960346
- Sponsor's protocol ID
- 015-238
- Status last verified
- May 2018
- First submitted
- 25 Mar 2016
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)
- ClinicalTrials.gov ID
- NCT03960346
- Acronym / sponsor ID
- 015-238
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives are to determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively. To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include:
- Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations
- Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations
- Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations As well as to associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
Detailed description
When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal Effects | Other | Procedure: Ablation with cryoenergyTo determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. Esophageal temperature probe is used during cryoablation to measure temperatures and then a 4-7 days post procedure esophagoscopy is performed to evaluate the physical effects on the esophagus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
- Age >18 years
- Planned AF cryoablation procedure
Key exclusion criteria (9 listed)
- LA diameter >55mm
- Severe LVH (LV wall ≥ 15mm)
- LA thrombus
- Decompensated heart failure
- Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
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 |
|---|---|---|
| Ablation with cryoenergyAlso: esophageal temperature-guided ablationEsophageal temperature-guided ablation using cryoengery and an esophageal temperature probe. | Procedure or surgery | Esophageal Effects |
Primary outcome
Rate of temperature decline
Time frame: Up to 3 years
Compare the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation using a esotest probe esophageal temperature probe to record the esophageal temperatures
Associate the development of symptoms
Time frame: Up to 3 years
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations using a symptom questionnaire and visualize the esophagus 4-7 days post procedure via esophagoscopy
2 secondary outcomes
Phrenic nerve injury
Time frame: Up to 3 years
Post procedure symptoms
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation with cryoenergy in people with Atrial Fibrillation, run by Baylor Research Institute.
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 3 inclusion and 9 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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of temperature decline (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 23 May 2019.