NL-OMON45131
Completed
Not 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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medisch Spectrum Twente
- Enrollment
- 222
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A randomized multicenter study evaluating efficacy, safety, tolerability and pharmacokinetics of AEB071 combined with tacrolimus or mycophenolate mofetil (MMF) vs. a tacrolimus-based control regimen in de novo liver transplant recipients.EUCTR2007-001776-36-GBovartis Pharma Services AG
Active, not recruiting
Not Applicable
Enterosgel® in the treatment of atopic dermatitis in adultsAtopic dermatitisSkin and Connective Tissue DiseasesISRCTN12307286Enteromed Ltd44
Not yet recruiting
Phase 1
Randomized multicenter clinical evaluation of Xiaoer Kechuanling oral liquid (concentrated type) in the intervention of respiratory syncytial virus pneumonia in children (syndrome of heat pathogen blocking lung)Respiratory syncytial virus pneumonia in childrenITMCTR2200006404The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Recruiting
Not Applicable
Home-based and group cognitive intervention programs in amnestic mild cognitive impairmentMental and behavioral disordersKCT0000328Inha University Hospital270
Recruiting
Phase 2
A Clinical Trial to study the effects of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral ConjunctivitisCTRI/2012/11/003145ovaBay Pharmaceutical Inc440