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Main
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Note: This record shows only the 20 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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR3319 |
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Date of registration:
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20/02/2012 |
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Primary sponsor: |
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Public title:
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Het mechanisme van hartritmestoornissen
bij patiënten met een hartspierziekte.
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Scientific title:
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Substrate and mechanisms of ventricular arrhythmia in nonischemic cardiomyopathy. -
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Date of first enrolment:
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31/10/2011 |
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Target sample size:
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220 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3319 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: 2 or more arms, non-randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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S.R.D.
Piers |
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Address:
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Department of Cardiology (C5-P)
Leids Universitair Medisch Centrum
Albinusdreef 2
2333 ZA
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5265389 |
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Email:
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S.R.D.Piers@lumc.nl |
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Affiliation:
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Name:
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S.R.D.
Piers |
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Address:
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Department of Cardiology (C5-P)
Leids Universitair Medisch Centrum
Albinusdreef 2
2333 ZA
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5265389 |
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Email:
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S.R.D.Piers@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with nonischemic cardiomyopathy and documented/suspected ventricular arrhythmia or an intermediate to high risk for ventricular arrhythmia;
2. Patients without nonischemic cardiomyopathy (controls) who are admitted for:
A. Coronary artery bypass graft surgery and who do not have prior myocardial infarction;
B. Aortic valve replacement.
Exclusion criteria: 1. Age < 18 yrs or > 80 yrs;
2. Inadequate patient competence;
3. Pregnancy;
4. Inability to comply with the protocol due to haemodynamic instability;
5. For nonischemic cardiomyopathy patients: prior myocardial infarction, infiltrative cardiac disease such as sarciodosis, amyloidosis or Chagas cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, hypertrophic cardiomyopathy, non-compaction cardiomyopathy and congenital heart disease.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Nonischemic cardiomyopathy
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Intervention(s)
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1. Intra-operative ablation of ventricular tachycardia in a small subset of patients who are admitted for cardiac surgery and have inducible ventricular arrhythmia with a suspected epicardial exit site during electrophysiological study. There is no control group for this group;
2. No intervention in the majority of patients.
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Primary Outcome(s)
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1. Inducibility of ventricular arrhythmias during electrophysiological study at baseline;
2. Type of induced ventricular arrhythmia during electrophysiological study at baseline;
3. Spontaneous ventricular arrhythmias during long-term follow-up;
4. Type of spontaneous ventricular arrhythmia during long-term follow-up.
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Secondary Outcome(s)
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1. Heart failure;
2. Cardiac mortality;
3. All-cause mortality.
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Secondary ID(s)
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NL37472.058.11
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Source(s) of Monetary Support
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Leiden University Medical Center (LUMC)
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