Safety Monitoring of Patients Having Pulmonary Vein Ablation (ROTEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590668
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
Allan L. Klein, The Cleveland Clinic

Brief 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 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:

  1. to see whether TEE measurements done before your ablation can tell us if your atrial fibrillation may come back after you ablation;
  2. to see if TEE measurements look different before and after your ablation;
  3. to see if a blood test can tell us if your atrial fibrillation may come back after your ablation;
  4. 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Diagnostic Test: Transesophageal Echocardiography

Detailed Description:


  1. Examine the structure and function of the left atrium, left atrial appendage and pulmonary veins before and after ablation.
  2. Compare the findings of transesophageal echo with those from intracardiac echo.
  3. Detect the incidence of pulmonary vein stenosis assessed by transesophageal echo compared to computed tomography.
  4. Assess for physiological predictors for recurrence of atrial fibrillation based on echocardiography.
  5. Determine whether biological markers such as B-type natriuretic peptide or C-reactive protein predict recurrence of atrial fibrillation.
  6. 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 Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2013

Intervention Details:
  • Diagnostic Test: Transesophageal Echocardiography
    Measurement of peak diastolic flow velocity
    Other Name: TEE

Primary Outcome Measures :
  1. incidence of pulmonry vein stenosis following PVI [ Time Frame: 3 month ]
    Peak diastolic flow velocity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pulmonry vein ablation subjects at the Cleveland Clinic

Inclusion Criteria:

  • Persistent or paroxysmal AF, resistanct to medical therapy
  • Normal renal function (creatininine <1.5

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590668

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Allan Klein, MD The Cleveland Clinic

Study Data/Documents: Publication  This link exits the site

Responsible Party: Allan L. Klein, Principal Investigator, The Cleveland Clinic Identifier: NCT00590668     History of Changes
Other Study ID Numbers: 6104
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allan L. Klein, The Cleveland Clinic:
atrial fibrillation
pulmonary vein ablation
pulmonary vein stenosis

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes