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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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12 December 2020 |
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Main ID: |
NCT02571218 |
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Date of registration:
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27/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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AF Substrate Mapping and Guided Ablation
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Scientific title:
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Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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81 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02571218 |
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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: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Carlo Pappone, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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I.R.C.C.S. Policlinico San Donato |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 - 85 years of age
- Persistent AF scheduled to undergo catheter ablation with approved standard indication
by ESC/EHRA guidelines
- First or second time ablation for persistent AF
- Ability to provide written informed consent for study participation and be willing and
able to comply with the study evaluations and follow up schedule
Exclusion Criteria:
- Had two or more previous AF ablation procedures
- Secondary AF
- Hyperthyroidism
- Left ventricular ejection fraction <30%
- NYHA functional class IV
- Left atrial area > 35 cm2
- Uncorrected severe valvular heart disease
- Contraindication to anticoagulation
- Presence of left atrial thrombus
- Recent (<6 Months) myocardial Infarction or unstable angina or coronary artery by-pass
- Thoracic surgery for congenital, valvular or aortic disease
- History of cerebrovascular accidents
- Pregnancy
- Significant comorbidities such as cancer, severe renal insufficiency requiring
hemodialysis, severe obstructive lung disease, cirrhosis, with a life expectancy less
than 2 years
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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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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Device: Substrate+mCPVA
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Device: mCPVA
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Primary Outcome(s)
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Long-term Clinical Success Rate
[Time Frame: 12 months]
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Secondary Outcome(s)
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Acute Ablation Procedure Outcome
[Time Frame: During Ablation]
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Secondary ID(s)
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SJM-CIP-10054
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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