Paroxysmal Atrial FibrillationNCT02998866
Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects
A study testing Esophageal Temperature-Guided Ablation in people with Paroxysmal Atrial Fibrillation, run by Baylor Research Institute.
Trial summary
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
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Esophageal Temperature-Guided Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 23 Feb 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
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 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
- Paroxysmal Atrial Fibrillation
- Being tested
- Esophageal Temperature-Guided Ablation
- Keywords
- Cryoballoon Pulmonary Vein Isolation, Esophageal Effects
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Temperature-Guided AblationProcedure or surgery
Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.
| Study group | Role | What they receive |
|---|---|---|
| Multi-center, prospective outcomes registry | Other | The study is a multi-center, prospective outcomes registry Receives: Procedure: Esophageal Temperature-Guided Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature Decline
- 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 procedure.
Measured: 90 days or when complications resolve
Measurements of esophagus to each pulmonary vein
II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
Measured: 90 days or when complications resolve
Create Recommendations for esophageal temperature-guided ablation
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
Measured: 90 days or when complications resolve
Assessment of additional Adverse Events
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
Measured: 90 days or when complications resolve
Secondary outcomes (1)
Data collection on Phrenic Injury
Assess participants with abnormal imaging and/or adverse events that are related to the treatment.
Measured: 90 days or when complications resolve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startNov 2015
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Deville, MD, Principal investigator, The Heart Hospital Baylor of Plano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998866
- Sponsor's protocol ID
- PI1002BD
- Status last verified
- Dec 2016
- First submitted
- 18 Nov 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects
- ClinicalTrials.gov ID
- NCT02998866
- Acronym / sponsor ID
- PI1002BD
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Cryoballoon Pulmonary Vein Isolation, Esophageal Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
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.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-center, prospective outcomes registry | Other | Procedure: Esophageal Temperature-Guided AblationThe study is a multi-center, prospective outcomes registry |
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 |
|---|---|---|
| Esophageal Temperature-Guided AblationEsophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience. | Procedure or surgery | Multi-center, prospective outcomes registry |
Primary outcome
Temperature Decline
Time frame: 90 days or when complications resolve
I. 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 procedure.
Measurements of esophagus to each pulmonary vein
Time frame: 90 days or when complications resolve
II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
Create Recommendations for esophageal temperature-guided ablation
Time frame: 90 days or when complications resolve
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
Assessment of additional Adverse Events
Time frame: 90 days or when complications resolve
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
1 secondary outcome
Data collection on Phrenic Injury
Time frame: 90 days or when complications resolve
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 21 Feb 2021.
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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.
Brian Deville, MD principal investigator
The Heart Hospital Baylor of Plano
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal Temperature-Guided Ablation in people with Paroxysmal 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 21 Feb 2021. 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?
Temperature Decline (time frame: 90 days or when complications resolve). The study lists 4 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 21 Feb 2021.