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 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stenosis, Pulmonary Vein Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transesophageal Echocardiography

Diagnostic Test

Measurement of peak diastolic flow velocity

Other names: TEE

Primary outcomes

incidence of pulmonry vein stenosis following PVI

Time frame: 3 month

Peak diastolic flow velocity

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Acronym: ROTEA

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2013
First posted: Jan 10, 2008
Registry last updated: Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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