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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 November 2021 |
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Main ID: |
NCT03056222 |
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Date of registration:
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14/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
CF² |
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Scientific title:
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CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation |
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Date of first enrolment:
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April 10, 2017 |
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Target sample size:
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360 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03056222 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Czechia
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Germany
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United Kingdom
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Contacts
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Name:
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Andreas Metzner, PD Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitäres Herz- und Gefäßzentrum UKE Hamburg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient must not have undergone a previous ablation for the treatment of PAF
- AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is
defined as recurrent (two or more) episodes of AF that terminate spontaneously in less
than seven days, usually less than 48 hours
Exclusion Criteria:
- Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting
more than 7 and less than 365 days
- More than 4 electrical cardioversions in the year prior to enrollment but not
including cardioversions performed within 48 hours of arrhythmia onset
- Documented left atrial thrombus on imaging
- Cannot be removed from anti-arrhythmic drugs for other reasons than atrial
fibrillation
- New York Heart Association (NYHA) functional Class III or Class IV heart failure
- Left ventricular ejection fraction < 30%
- Left atrial size > 55 mm as measured in the parasternal antero-posterior view
- Myocardial infarction within 60 days prior to enrolment
- Woman of childbearing potential who is pregnant, lactating or not using adequate birth
control
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Paroxysmal Atrial Fibrillation
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Intervention(s)
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Device: Ablation catheter
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Primary Outcome(s)
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Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
[Time Frame: 12 months post procedure]
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Secondary Outcome(s)
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Acute procedure success
[Time Frame: 30 minutes post procedure]
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Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
[Time Frame: 12 months post procedure]
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Procedure and fluoroscopy time
[Time Frame: During procedure]
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Incidence of peri-procedural complications
[Time Frame: From procedure to 12 months post procedure]
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Secondary ID(s)
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CF2 Rev.1 IMP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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