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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22465
Enrollment
125
Registered
2015-01-20
Start date
2015-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scar related ventricular tachycardia dutch: ventrikel tachycardie

Interventions

One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.

Sponsors

ErasmusMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

MeasureTime frame
The 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

MeasureTime frame
The secondary endpoints are procedure success and safety

Contacts

Public ContactAstrid Hendriks

Erasmus MC - Postbus 2040

a.a.hendriks@erasmusms.nl+31-10-7033318

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)