NCT02801175

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

June 13, 2016

Last Update Submit

June 13, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • LAA-EFV

    Left atrial appendage emptying flow velocity

    1 month

Secondary Outcomes (1)

  • LAA-EFV

    3 months

Study Arms (2)

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

Pulmonary vein isolationPROCEDURE
CryoballoonRF

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ablation-naive patients with paroxysmal AFib

You may qualify if:

  • Paroxysmal atrial fibrillation, no absolute contraindication for anticoagulation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, 12461, Greece

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Spyridon Deftereos, MD

CONTACT

2105832352spdeftereos@med.uoa.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 15, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

GR(1)