NCT02074566

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

Completed NA Last updated 12 March 2020

What this trial tests

NA trial testing Cryoballoon ablation in Atrial Fibrillation in 222 participants. Completed in 13 February 2019.

Timeline

14 August 2014

Primary endpoint
8 March 2018

13 February 2019

Quick facts

Lead sponsor	Harald Verheij
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	222
Start date	14 August 2014
Primary completion	8 March 2018
Estimated completion	13 February 2019
Sites	2 locations across Netherlands

Drugs / interventions tested

• Cryoballoon ablation

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Harald Verheij

Who can join

Adults 18 to 70, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study.
   Molenaar MMD, Timmermans CC, Hesselink T, Scholten MF, et al · · 2019 · cited 11× · PMID 30756393 · DOI 10.1111/pace.13626