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

Completed

• Conditions: Atrial Fibrillation; 10007521

• Registration Number: NL-OMON45131
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 222

Inclusion Criteria

* Paroxysmal atrial fibrillation eligible for PVI according to current international guidelines.
* Age < 75 years.
* Willing and able to sign informed consent.
* Willing to and capable of following the requested study procedures.

Exclusion Criteria

* Age < 18 years.
* Pregnancy
* Life or follow-up expectancy < 12 months.
* Previous PVI.
* Contrast allergy.
* Creatin clearance level < 60.
* LVEF < 40%
* Abnormal left atrium anatomy defined as number of PV*s * 2 per side or LA diameter >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute success (=entrance and exitblock) of pulmonary vein isolation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a) (Imminent) complications, defined as:<br /><br>1. Phrenic nerve palsy or diminishment of diaphragm excursion during<br /><br>cryo-ablation.<br /><br>2. Temperatures reaching <12 C in the oesopaghus during cryoablation.<br /><br>3. Other complications such as delayed gastric emptying, pericardial<br /><br>fluid/tamponade, hemoptoe, vascular complications.<br /><br>b) Acute success of PVI after 1 freezing cycle<br /><br>c) Duration of thaw phase (= time between end of freezing to automatic<br /><br>deflation of the balloon) related to acute success of PVI<br /><br>d) Procedure time, fluoroscopy time, amount of contrast used<br /><br>e) LET development during and after ablation and relation of LET with balloon<br /><br>temperatures measured by the console.<br /><br>f) AF recurrence after 1 year follow up.</p><br>