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Safety Monitoring of Patients Having Pulmonary Vein Ablation (ROTEA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allan L. Klein, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00590668
First received: December 26, 2007
Last updated: February 2, 2017
Last verified: February 2017
  Purpose

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 Intervention
Atrial Fibrillation
Diagnostic Test: Transesophageal Echocardiography

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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


Enrollment: 42
Actual Study Start Date: May 2004
Study Completion Date: April 2013
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Diagnostic Test: Transesophageal Echocardiography
    Measurement of peak diastolic flow velocity
    Other Name: TEE
Detailed Description:

Aims

  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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590668

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

Study Data/Documents: Publication  This link exits the ClinicalTrials.gov site

Responsible Party: Allan L. Klein, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00590668     History of Changes
Other Study ID Numbers: 6104 
Study First Received: December 26, 2007
Last Updated: February 2, 2017
Individual Participant Data  
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 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

ClinicalTrials.gov processed this record on February 17, 2017