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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: |
NCT03141606 |
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Date of registration:
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26/04/2017 |
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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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Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response
iLAV |
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Scientific title:
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Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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230 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03141606 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient with left ventricular ejection fraction = 35%, II, III or IV NYHA Class, even
if optimal medical therapy.
- Patients with standard indication to CRT according current guideline, sinus rhythm at
implantation, LBBB and QRS duration >= 120 ms
- Patients who will undergo to a new CRT-defibrillator system implantation
- Patients who are able to understand and sign the informed consent
- Patients who are able to attend all required follow-up visits at the study centerfor
24 months
Exclusion Criteria:
- Age < 18 years
- Women who are pregnant or who are planning to become pregnant
- Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the
90 days preceding the implantation
- Patients with organic mitral valve disease
- Patients with prosthetic heart valves
- Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart
transplantation, patients with CRT devices
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Left Atrial Volume
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Primary Outcome(s)
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CRT Predictor Index
[Time Frame: 6 months]
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Cardiac remodelling
[Time Frame: 6 months]
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Secondary Outcome(s)
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Atrial arrhythmias
[Time Frame: 24 months]
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Clinical benefit
[Time Frame: 12 months]
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Cardiac remodelling
[Time Frame: 6 months]
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Ventricular arrhythmias
[Time Frame: 24 months]
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Secondary ID(s)
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20140002277
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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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