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Effect of Cryoballoon and RF Ablation on Left Atrial Function

NCT02611869 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-23

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Cryoballoon

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

PROCEDURE

RF ablation

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

Sponsors & Collaborators

  • Attikon Hospital

    collaborator OTHER

  • G.Gennimatas General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-05-31
Completion
2017-09-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611869 on ClinicalTrials.gov