Effect of Left Atrial Ablation on Left Atrial Appendage E... | NCT02801175

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

NCT02801175

Sponsor

National and Kapodistrian University of Athens

Status

Unknown status

Last Update Posted

Jun 15, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Pulmonary vein isolation

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Jun 13, 2016

First Submission Date that Met QC Criteria

Jun 13, 2016

First Posted Date

Jun 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2016

Last Update Posted Date

Jun 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Spyridon Deftereos, Associate Professor of Cardiology, National and Kapodistrian University of AthensPrincipal Investigator

Lead Sponsor

National and Kapodistrian University of AthensOTHER

Collaborators

Name	Class
G.Gennimatas General Hospital	OTHER

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RF		Patients with paroxysmal atrial fibrillation slated for radiofrequency pulmonary vein isolation	Procedure: Pulmonary vein isolation
Cryoballoon		Patients with paroxysmal atrial fibrillation slated for cryoballoon pulmonary vein isolation	Procedure: Pulmonary vein isolation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary vein isolation	Procedure		Cryoballoon RF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LAA-EFV	Left atrial appendage emptying flow velocity	1 month

Secondary Outcomes

Measure	Description	Time Frame
LAA-EFV	Left atrial appendage emptying flow velocity	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Ablation-naive patients with paroxysmal AFib

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Spyridon Deftereos, MD	Contact	2105832352		spdeftereos@med.uoa.gr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Dept. of Cardiology, Univ of Athens Med Sch	Recruiting	Athens		12461	Greece

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided