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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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13 June 2016 |
Main ID: |
NCT02732626 |
Date of registration:
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23/03/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The Low Voltage Guided Ablation Trail of Persistent Atrial Fibrillation
ERASE-AF |
Scientific title:
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The Low Voltage Guided Ablation Trail of Persistent Atrial Fibrillation |
Date of first enrolment:
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April 2016 |
Target sample size:
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320 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02732626 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Austria
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Germany
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Contacts
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Name:
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Christopher Piorkowski, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Heart Center Dresden |
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Name:
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Robert Schönbauer, MD |
Address:
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Telephone:
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+432236900427020 |
Email:
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robert.schoenbauer@moedling.lknoe.at |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Symptomatic patients with persistent AF documented by 12 lead ECGs (Persistent AF is
defined as an AF episode which lasts longer than 7 days, Persistent AF which lasted
longer than 12 months will be defined as long standing persistent AF.)
- Age 18 - 80 years, both genders
- Patient is willing to participate in the study (signed written informed consent)
- Patient is willing and available to perform all follow ups.
Exclusion Criteria:
- Atrial fibrillation due to reversible causes
- Any contraindication for AF ablation
- Contraindications to anticoagulation
- CVA/TIA in the past 6 months
- Previous left atrial catheter ablation
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Persistent Atrial Fibrillation
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Intervention(s)
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Procedure: radiofrequency ablation
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Primary Outcome(s)
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recurrence of atrial fibrillation
[Time Frame: 12 months]
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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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