Safety Monitoring of Patients Having Pulmonary Vein Ablation

NCT00590668 | Completed

• 1 other identifier: 6104
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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:

1. 1.to see whether TEE measurements done before your ablation can tell us if your atrial fibrillation may come back after you ablation;
2. 2.to see if TEE measurements look different before and after your ablation;
3. 3.to see if a blood test can tell us if your atrial fibrillation may come back after your ablation;
4. 4.to look at how often pulmonary vein narrowing is found by TEE compared to how often it is found by CT scan.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pulmonary vein ablation; pulmonary vein stenosis

Outcome Measures

Primary Outcomes (1)

• incidence of pulmonry vein stenosis following PVI

  Peak diastolic flow velocity

  3 month

Interventions

Transesophageal Echocardiography DIAGNOSTIC_TEST

Measurement of peak diastolic flow velocity

Also known as: TEE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pulmonry vein ablation subjects at the Cleveland Clinic

You may qualify if:

• Persistent or paroxysmal AF, resistanct to medical therapy
• Normal renal function (creatininine \<1.5

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stenosis, Pulmonary Vein

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Allan Klein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: May 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2013
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)