Clinical Trial: Safety Monitoring of Patients Having Pulmonary Vein Ablation
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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
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:
- to see whether TEE measurements done before your ablation can tell us if your atrial fibrillation may come back after you ablation;
- to see if TEE measurements look different before and after your ablation;
- to see if a blood test can tell us if your atrial fibrillation may come back after your ablation;
- 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).
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 echocardi
Sponsor: The Cleveland Clinic
Current Primary Outcome: incidence of pulmonry vein stenosis following PVI [ Time Frame: 3 month ]
Original Primary Outcome: incidence of pulmonry vein stenosis following PVI [ Time Frame: 3 month ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Cleveland Clinic
Dates:
Date Received: December 26, 2007
Date Started: May 2004
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017
