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NCT00590668 · ClinicalTrials.gov registry record
Safety Monitoring of Patients Having Pulmonary Vein Ablation
A clinical trial of Atrial Fibrillation, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 42
- Enrollment target
- 1
- Study location
NCT00590668: Completed study of Atrial Fibrillation, sponsored by The Cleveland Clinic.
NCT00590668 is a study of Atrial Fibrillation that has completed, run by The Cleveland Clinic. The registered enrollment target is 42 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590668, a study of Atrial Fibrillation, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Peak diastolic flow velocity
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Transesophageal Echocardiography
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2004-05 |
| Est. Completion | 2013-04 |
What the finished NCT00590668 record still lists
NCT00590668 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Transesophageal Echocardiography is the first listed.
NCT00590668 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00590668 about?
NCT00590668 is a clinical study titled "Safety Monitoring of Patients Having Pulmonary Vein Ablation". 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...
What is the current status of trial NCT00590668?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2004-05. Estimated completion is 2013-04.
What conditions does trial NCT00590668 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT00590668?
The interventions under investigation include: Transesophageal Echocardiography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT00590668?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00590668 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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