Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity

NCT ID: NCT02801175

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-31

Brief Summary

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Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography (TEE) immediately before and following left atrial ablation (1 month post). The change in LAA-EFV will be compared between the two groups (RF versus Cryo).

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RF

Patients with paroxysmal atrial fibrillation slated for radiofrequency pulmonary vein isolation

Pulmonary vein isolation

Intervention Type PROCEDURE

Cryoballoon

Patients with paroxysmal atrial fibrillation slated for cryoballoon pulmonary vein isolation

Pulmonary vein isolation

Intervention Type PROCEDURE

Interventions

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Pulmonary vein isolation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Paroxysmal atrial fibrillation, no absolute contraindication for anticoagulation

Exclusion Criteria

Previous cardiac surgery Previous left atrial ablation History of cerebrovascular event Presence of LAA thrombus Inability to provide informed consent
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G.Gennimatas General Hospital

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Spyridon Deftereos

Associate Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Dept. of Cardiology, Univ of Athens Med Sch

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Spyridon Deftereos, MD

Role: CONTACT

2105832352

Facility Contacts

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Spyridon Deftereos, MD

Role: primary

2105832352

Other Identifiers

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1/13.6.2016

Identifier Type: -

Identifier Source: org_study_id

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