A prospective randomized multicentre efficacy study on defining the optimal cryoballoon duration therapy for treatment of atrial fibrillation: The 1-2-3 study

A prospective randomized multicentre efficacy study on defining the optimal cryoballoon duration therapy for treatment of atrial fibrillation: The 1-2-3 study - The 1-2-3 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45131

Enrollment

222

Registered

2014-02-18

Start date

2014-04-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Interventions

Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase*.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Paroxysmal atrial fibrillation eligible for PVI according to current international guidelines. * Age

Exclusion criteria

Exclusion criteria: * Age 50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or >40cc/m2. This will lead to exclusion after inclusion but before randomisation.

Design outcomes

Primary

Measure	Time frame
Acute success (=entrance and exitblock) of pulmonary vein isolation.	—

Secondary

Measure	Time frame
a) (Imminent) complications, defined as: 1. Phrenic nerve palsy or diminishment of diaphragm excursion during cryo-ablation. 2. Temperatures reaching	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)