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Safety Monitoring of Patients Having Pulmonary Vein Ablation

NCT00590668 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2017-02-03

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Transesophageal Echocardiography

Measurement of peak diastolic flow velocity

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Allan Klein, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590668 on ClinicalTrials.gov