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Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study

NCT02074566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2020-03-12

No results posted yet for this study

Summary

Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.

Conditions

Interventions

OTHER

Cryoballoon ablation

PVI using cryoballoon

Sponsors & Collaborators

  • Thorax Centrum Twente

    collaborator OTHER

  • Academisch Ziekenhuis Maastricht

    collaborator OTHER

  • Harald Verheij

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-14
Primary Completion
2018-03-08
Completion
2019-02-13

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT02074566 on ClinicalTrials.gov