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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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8 March 2021 |
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Main ID: |
NCT02217657 |
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Date of registration:
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14/08/2014 |
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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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SmartTouch Catheter for Left Anterior Line - SmarT Line Study
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Scientific title:
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"Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02217657 |
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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: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Heidi Estner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Munich University Clinic, Campus Großhadern |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with symptomatic atrial fibrillation and additional substrate modification or
perimitral flutter
- Patients with persistent atrial fibrillation
- Patients with perimitral flutter
- Patients with recurrence after a circumferential PV isolation procedure
- Patients with paroxysmal atrial fibrillation and AF episodes lasting > 7 days
- Patients (>18 und <80 Jahre)
Exclusion Criteria:
- moderate to severe valvular heart disease,
- congenital heart disease
- reduced left ventricular function (ejection fraction <35%)
- any reversible cause for atrial fibrillation (e.g. hyperthyroidism)
- intracardiac thrombi documented by transesophageal echocardiography
- myocardial infarction within 3 months, cardiac surgery in the previous three months
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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Persistent Atrial Fibrillation
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Intervention(s)
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Device: Thermocool Smart Touch Catheter
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Primary Outcome(s)
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Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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Achievement of primary endpoint (bidirectional conduction block at an anterior line)
[Time Frame: 6 months]
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Secondary ID(s)
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MucM001-13
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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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