NCT02611869

Brief Summary

120 consecutive patients with paroxysmal AF, slated for PV isolation, will be randomly assigned to RF or cryoballoon ablation (in a 1:2 allocation scheme). Real-time 3D echocardiography (RT3DE) will be performed before the ablation procedure and 1 month post-ablation. The RT3DE datasets will be stored digitally and quantitative analyses will be performed off-line at a core echo laboratory. Quantification of left atrial volumes will be performed and left atrial functional quantification will be performed by calculating the following indices: Left atrial ejection fraction, Active atrial emptying fraction, Passive atrial emptying fraction, Atrial expansion index. All patients will be hospitalized for 48 hours post-ablation. Blood samples will be obtained at 12-hour intervals to measure troponin T with a high-sensitivity assay, as well as other biochemical parameters.

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
120

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

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

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

November 19, 2015

Last Update Submit

November 19, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Change in left atrial ejection fraction

    30 days

Secondary Outcomes (1)

  • Maximal post-procedural troponin T

    48 h

Study Arms (2)

Cryoballoon

EXPERIMENTAL
Procedure: Cryoballoon

RF ablation

ACTIVE COMPARATOR
Procedure: RF ablation

Interventions

CryoballoonPROCEDURE

Pulmonary vein isolation by cryoablation using a 2nd generation cryoballoon catheter

Cryoballoon
RF ablationPROCEDURE

Pulmonary vein isolation by radiofrequency current ablation using a touch-force-sensing irrigated catheter

RF ablation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least two AF episodes within the last 12 months (either self-terminating within 7 days or cardioverted, medically or electrically, in less than 48 hours),
  • AF episodes should have been symptomatic on at least 2 occasions within the last 12 months,
  • Failure of at least one class I or III antiarrhythmic to prevent AF paroxysms,
  • Age 40-80 years old.

You may not qualify if:

  • Previous left atrial ablation procedure,
  • Left atrial diameter \>50 mm on TTE (parasternal long axis view),
  • Known primary electrical heart disease (e.g. Brugada syndrome),
  • Presence of atrial thrombus,
  • Prosthetic valve at any position,
  • Moderate/severe mitral stenosis,
  • Severe mitral regurgitation,
  • Active infectious disease or malignancy,
  • Moderate or severe hepatic impairment (Child-Pugh class B or C),
  • Severe renal failure (estimated glomerular filtration rate \<20 ml/min/1.73 m2),
  • Participation in a different research protocol (current or within 1 year),
  • Inability or unwillingness to adhere to standard treatment or to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiology, Athens General Hospital "G. Gennimatas"

Athens, 11527, Greece

RECRUITING

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

Athens, Greece

RECRUITING

Related Publications (1)

  • Giannopoulos G, Kekeris V, Vrachatis D, Kossyvakis C, Ntavelas C, Tsitsinakis G, Koutivas A, Tolis C, Angelidis C, Deftereos S. Effect of pulmonary vein isolation on left atrial appendage flow in paroxysmal atrial fibrillation. Pacing Clin Electrophysiol. 2018 Sep;41(9):1129-1135. doi: 10.1111/pace.13436. Epub 2018 Aug 7.

    PMID: 30028029DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Spyridon Deftereos, MD

CONTACT

spdeftereos@med.uoa.gr

Charalampos Kossyvakis, MD

CONTACT

ckossyvakis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 23, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

November 23, 2015

Record last verified: 2015-11

Locations

GR(2)