Atrial FibrillationROTEANCT00590668
Safety Monitoring of Patients Having Pulmonary Vein Ablation
An observational study of Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Subjects eligible for this study have an irregular heartbeat called atrial fibrillation (AF)and who are scheduled for a procedure that involves applying electrical energy in your pulmonary veins, which is usually the site where this abnormal rhythm begins, or pulmonary vein ablation We will examine the size and… 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?
- Transesophageal Echocardiography
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Apr 2013
- Phase
- Observational
- 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
Study population: Pulmonry vein ablation subjects at the Cleveland Clinic
Who may be able to join
- Persistent or paroxysmal AF, resistanct to medical therapy
- Normal renal function (creatininine <1.5
Who cannot join
- Unable or unwilling to give informed consent
- History of esophageal diseases, such as stricture, vaices or cancer
- Inability to swallow TEE probe
- Severe mitral stenosis
- Severe mitral reguritation
- Cardiothoracic surgery within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Vein Ablation for Atrial Fibrillation: Safety Monitoring by Transesphoageal Echo, Intracardiac Echo and Computed Tomography and Assessment of Predictors of Recurrence and of Hypercoagulable State
Subjects eligible for this study have an irregular heartbeat called atrial fibrillation (AF)and who are scheduled for a procedure that involves applying electrical energy in your pulmonary veins, which is usually the site where this abnormal rhythm begins, or pulmonary vein ablation
We will examine the size and function of the left atrium (one of the 4 chambers of your heart) and the pulmonary veins before and after your ablation. This will be done by getting extra measurements during tests you will be having done which are ICE (intra cardiac echocardiography), TEE (transesophageal echocardiography) and CT scan (computed tomography), and drawing some blood samples.
Read more
The purpose of getting these extra measurements and blood samples is:
- to see whether TEE measurements done before your ablation can tell us if your atrial fibrillation may come back after you ablation;
- to see if TEE measurements look different before and after your ablation;
- to see if a blood test can tell us if your atrial fibrillation may come back after your ablation;
- to look at how often pulmonary vein narrowing is found by TEE compared to how often it is found by CT scan.
During the clinically indicated tests the doctor has ordered (TEE, ICE, CT scan), there will be additional measurements taken as a part of this research. This means that the TEE exam will last an additional 10-15 minutes, and the ICE procedure will last an additional 5-10 minutes. There is no additional time needed for the CT scan. In addition, we will be drawing 20 cc of blood (approximately four teaspoons).
The regularly scheduled follow up visit is usually three months after your ablation, we will again be getting some extra measurements from the TEE and CT scan. This will add about 10-15 minutes to the TEE test, but no additional time will be needed for the CT scan. In addition, we will be drawing 10 cc of blood drawn (approximately two teaspoons). A ventilation-perfusion scan of the lungs will also be performed as part of standard clinical care if significant PV stenosis is found by CT and/or TEE.
Read the detailed description
Aims
- Examine the structure and function of the left atrium, left atrial appendage and pulmonary veins before and after ablation.
- Compare the findings of transesophageal echo with those from intracardiac echo.
- Detect the incidence of pulmonary vein stenosis assessed by transesophageal echo compared to computed tomography.
- Assess for physiological predictors for recurrence of atrial fibrillation based on echocardiography.
- Determine whether biological markers such as B-type natriuretic peptide or C-reactive protein predict recurrence of atrial fibrillation.
- Assess if markers of coagulation such as D-dimer and prothrombin factor 1.2 are increased in atrial fibrillation and could predict thromboembolic risk.
General Procedures Prior to ablation, blood will be drawn for measuring c-reactive protein, brain natriuretic polypeptide, D-dimer and prothrombin fragment 1.2. A transesopahegeal echocardiogram and an intracardiac echocardiogram will be performed. Then following sterile techniques, standard catheters will be passed through veins and positioned into the heart using X-ray guidance, and will cross the wall that divides the upper chambers of the heart so that the left atrium can be reached.The catheters will be used to trigger sites that originate the anomalous rhythm and once these are identified the generator will deliver radiofrequency energy to destroy the areas that cause irregular beats. After ablation follow-up visits will be done at one, three, six and twelve months. During that time several tests such as electrocardiograms, 24 hour Holter recording, computed tomography of the heart, transesophageal echocardiogram and repeated blood drawing to measure c-reactive protein, brain natriuretic peptide, D-dimer and prothrombin fragment 1.2 will be done.
- Conditions
- Atrial Fibrillation
- Being tested
- Transesophageal Echocardiography
- Keywords
- atrial fibrillation, pulmonary vein ablation, pulmonary vein stenosis
- Medical subject headings
- Atrial Fibrillation, Stenosis, Pulmonary Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyDiagnostic test
Also called TEE
Measurement of peak diastolic flow velocity
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pulmonry vein stenosis following PVI
Peak diastolic flow velocity
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startMay 2004
- Primary completionApr 2008
- Study completionApr 2013
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.
- More trials run by The Cleveland ClinicThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan L. Klein, The Cleveland Clinic
- Investigators
- Allan Klein, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590668
- Sponsor's protocol ID
- 6104
- Acronym
- ROTEA
- Status last verified
- Feb 2017
- First submitted
- 26 Dec 2007
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Ablation for Atrial Fibrillation: Safety Monitoring by Transesphoageal Echo, Intracardiac Echo and Computed Tomography and Assessment of Predictors of Recurrence and of Hypercoagulable State
- ClinicalTrials.gov ID
- NCT00590668
- Acronym / sponsor ID
- ROTEA / 6104
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, pulmonary vein ablation, pulmonary vein stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2004 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Jan 2008 (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.
Subjects eligible for this study have an irregular heartbeat called atrial fibrillation (AF)and who are scheduled for a procedure that involves applying electrical energy in your pulmonary veins, which is usually the site where this abnormal rhythm begins, or pulmonary vein ablation
We will examine the size and function of the left atrium (one of the 4 chambers of your heart) and the pulmonary veins before and after your ablation. This will be done by getting extra measurements during tests you will be having done which are ICE (intra cardiac echocardiography), TEE (transesophageal echocardiography) and CT scan (computed tomography), and drawing some blood samples.
The purpose of getting these extra measurements and blood samples is:
- to see whether TEE measurements done before your ablation can tell us if your atrial fibrillation may come back after you ablation;
- to see if TEE measurements look different before and after your ablation;
- to see if a blood test can tell us if your atrial fibrillation may come back after your ablation;
- to look at how often pulmonary vein narrowing is found by TEE compared to how often it is found by CT scan.
During the clinically indicated tests the doctor has ordered (TEE, ICE, CT scan), there will be additional measurements taken as a part of this research. This means that the TEE exam will last an additional 10-15 minutes, and the ICE procedure will last an additional 5-10 minutes. There is no additional time needed for the CT scan. In addition, we will be drawing 20 cc of blood (approximately four teaspoons).
The regularly scheduled follow up visit is usually three months after your ablation, we will again be getting some extra measurements from the TEE and CT scan. This will add about 10-15 minutes to the TEE test, but no additional time will be needed for the CT scan. In addition, we will be drawing 10 cc of blood drawn (approximately two teaspoons). A ventilation-perfusion scan of the lungs will also be performed as part of standard clinical care if significant PV stenosis is found by CT and/or TEE.
Detailed description
Aims
- Examine the structure and function of the left atrium, left atrial appendage and pulmonary veins before and after ablation.
- Compare the findings of transesophageal echo with those from intracardiac echo.
- Detect the incidence of pulmonary vein stenosis assessed by transesophageal echo compared to computed tomography.
- Assess for physiological predictors for recurrence of atrial fibrillation based on echocardiography.
- Determine whether biological markers such as B-type natriuretic peptide or C-reactive protein predict recurrence of atrial fibrillation.
- Assess if markers of coagulation such as D-dimer and prothrombin factor 1.2 are increased in atrial fibrillation and could predict thromboembolic risk.
General Procedures Prior to ablation, blood will be drawn for measuring c-reactive protein, brain natriuretic polypeptide, D-dimer and prothrombin fragment 1.2. A transesopahegeal echocardiogram and an intracardiac echocardiogram will be performed. Then following sterile techniques, standard catheters will be passed through veins and positioned into the heart using X-ray guidance, and will cross the wall that divides the upper chambers of the heart so that the left atrium can be reached.The catheters will be used to trigger sites that originate the anomalous rhythm and once these are identified the generator will deliver radiofrequency energy to destroy the areas that cause irregular beats. After ablation follow-up visits will be done at one, three, six and twelve months. During that time several tests such as electrocardiograms, 24 hour Holter recording, computed tomography of the heart, transesophageal echocardiogram and repeated blood drawing to measure c-reactive protein, brain natriuretic peptide, D-dimer and prothrombin fragment 1.2 will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonry vein ablation subjects at the Cleveland Clinic
Key inclusion criteria (2 listed)
- Persistent or paroxysmal AF, resistanct to medical therapy
- Normal renal function (creatininine <1.5
Key exclusion criteria (6 listed)
- Unable or unwilling to give informed consent
- History of esophageal diseases, such as stricture, vaices or cancer
- Inability to swallow TEE probe
- Severe mitral stenosis
- Severe mitral reguritation
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 |
|---|---|---|
| Transesophageal EchocardiographyAlso: TEEMeasurement of peak diastolic flow velocity | Diagnostic test | – |
Primary outcome
incidence of pulmonry vein stenosis following PVI
Time frame: 3 month
Peak diastolic flow velocity
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 3 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Allan Klein, MD principal investigator
The Cleveland Clinic
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 The Cleveland Clinic 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 6 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 3 Feb 2017. 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?
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?
incidence of pulmonry vein stenosis following PVI (time frame: 3 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 3 Feb 2017.