search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First procedure Versus a Stepwise Approach a randomized controlled trial


- candidate number21593
- NTR NumberNTR5136
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jan-2015
- Secondary IDs2014-248 MEC
- Public TitleVentricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First procedure Versus a Stepwise Approach a randomized controlled trial
- Scientific TitleVentricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First procedure Versus a Stepwise Approach a randomized controlled trial
- ACRONYMepilogue
- hypothesisWe hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
- Healt Condition(s) or Problem(s) studiedVentricular tachycardia
- Inclusion criteria1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers

2. history of ischemic heart disease

3. ICD carrier or ICD implantation planned after the ablation

4. informed written consent
- Exclusion criteria1. current unstable angina as defined by current european guidelines

2. AMI < 30 days or in case of incessant VT < 14 days

3. absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)

4. significant coronary stenosis approachable and clinically relevant for intervention

5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiograpy or MRI

6. previous pericarditis

7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions

8. previous thoracic radiation therapy

9. contra-indication for general anaesthesia

10. age below 18 years
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2015
- planned closingdate1-jun-2019
- Target number of participants125
- InterventionsOne group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
- Primary outcomeThe main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on ICD interrogation - between the two ablation groups
- Secondary outcomeThe secondary endpoints are procedure success and safety
- Timepoints2 years follow-up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Astrid Hendriks
- CONTACT for SCIENTIFIC QUERIES T. Szili-Torok
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Medtronic B.V.
- Publications
- Brief summaryThe objective of this study is to show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.

Study design: Multicenter prospective open randomized controlled trial.

Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
- Main changes (audit trail)
- RECORD20-jan-2015 - 12-okt-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl