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De SPECTACLE studie


- candidate number21995
- NTR NumberNTR5205
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-apr-2015
- Secondary IDsNL51350.044.15 
- Public TitleDe SPECTACLE studie
- Scientific TitleCorrelation between speckle tracking determined left atrial strain measurements and voltage mapping in patients with paroxysmal atrial fibrillation undergoing catheter ablation: the SPECTACLE study
- ACRONYMSPECTACLE
- hypothesisWe hypothesized that there should be a relationship between LA structural remodeling assessed by invasive voltage mapping in the left atrium and LA functional remodeling assessed by strain and strain rate imaging in patients with AF.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation
- Inclusion criteria-Eligible to undergo percutaneous radiofrequent catheter ablation of atrial fibrillation.
-Sinus rhythm during echocardiography
-Age >18 years
-Expected follow up >12 months
- Exclusion criteria-Previous PVI or MAZE procedure.
-Emphysema
-Unable to provide informed consent.
-Pregnancy
-Presence of pacemaker or ICD
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2015
- planned closingdate1-jun-2017
- Target number of participants50
- InterventionsMeasurement of left atrial voltage and echocardiographic strain measurements
- Primary outcomeCorrelation between speckle tracking determined global strain measurement and percentage of low voltage points in the left atrium.
- Secondary outcome-Recurrence of atrial fibrillation within 12 months after a blanking period of 3 months defined as registration of atrial fibrillation on ECG or episode lasting >30 seconds on Holter/Vitaphone recording.
-Correlation between strain/strain rate measurements and regional percentage of low voltage in the LA.;
-Correlation between laboratory values and voltage measurements
-Predictive value of strain/strain rate measurements and low voltage percentage for recurrent atrial fibrillation after catheter ablation.
-Quality of life before and after PVI measured with SF-12 questionnaire
- Timepoints1 year
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES T. Hesselink
- CONTACT for SCIENTIFIC QUERIES T. Hesselink
- Sponsor/Initiator MST Enschede
- Funding
(Source(s) of Monetary or Material Support)
Cardio Research Enschede BV
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD21-apr-2015 - 11-nov-2015


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