|- candidate number||11147|
|- NTR Number||NTR3340|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-feb-2012|
|- Secondary IDs||P07.257 CME LUMC|
|- Public Title||Cryoablatie van Ventriculaire Ritmestoornissen tijdens LV Reconstructie.|
|- Scientific Title||Encircling Cryoablation of Ventricular Arrhythmia Concomitant with Left Ventricular Reconstruction. A Comparison of the Effectivity of Combined Endo- and Epicardial Cryoablation versus Endocardial
|- hypothesis||Combined endocardial-epicardial encircling cryoablation of the aneurysm scar borderzone during LV reconstructive surgery is more effective in treating ventricular arrhythmias than endocardial encircling cryoablation alone.|
|- Healt Condition(s) or Problem(s) studied||Ventricular arrhythmias, LV reconstruction, Dor|
|- Inclusion criteria||1. Patients referred for LV reconstruction according to Dor;|
2. Spontaneous or inducible ventricular arrhythmias.
|- Exclusion criteria||1. Age <18 years;|
2. Inability to comply with the protocol.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-nov-2008|
|- planned closingdate||31-dec-2012|
|- Target number of participants||40|
|- Interventions||Endocardial encircling cryoablation (control) with additional epicardial cryoablation (study group) at the aneurysm scar borderzone with overlapping applications (up to -150C for 90s).|
|- Primary outcome||>50ms conduction delay or conduction block between the aneurysm scar, encircled by cryoablation, and the healthy myocardium.
Conduction properties are measured before and after cryoablation via temporary epicardial pacemaker leads between the aneurysm scar and the healthy LV and RV. All electrograms are stored on an electrophysiological recording system for off-line analysis.|
|- Secondary outcome||1. Inducibility during post operative electrophysiological study of sustained monomorphic ventricular arrhythmias lasting >30s or requiring termination because of hemodynamic compromise;|
2. Sustained ventricular arrhythmias recorded on ICD during follow-up.
|- Timepoints||1. Patients are checked at the outpatient clinic and ICDs are interrogated for ventricular arrhythmia recordings every 3-6 months for at least 1 year;|
2. After inclusion of 10, 20 and 30 patients an interim analysis will be performed.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. K. Zeppenfeld|
|- CONTACT for SCIENTIFIC QUERIES||Dr. K. Zeppenfeld|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Cardiology|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center, Department of Cardiothoracic Surgery|
|- Brief summary||This study will test the hypothesis that the combined endocardial- epicardial cryoablation therapy during LV reconstructive surgery, but not the endocardial cryoablation, will result in significant conduction delay or block and that the combined approach will be more effective in preventing reinducibility and spontaneous occurrence of ventricular arrhythmias. The main study parameters are acute conduction properties across the cryoablation line, inducibility of ventricular arrhythmias before and after surgery and sustained ventricular arrhythmias recorded by the ICD.|
|- Main changes (audit trail)|
|- RECORD||16-feb-2012 - 23-mrt-2012|