NL-OMON45131CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medisch Spectrum Twente
- Enrollment
- 222
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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