Skip to content

Image Integration for Scar-Related Ventricular Tachycardia Ablation

Image Integration for Scar-Related Ventricular Tachycardia Ablation - INVENTA-1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54201
Enrollment
15
Registered
2021-12-24
Start date
2021-05-17
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

ventricular tachycardia / fast abnormal heart rate

Interventions

VT RF ablation with support from CARTBox-CA image integration. CARTBox-CA integrates 3D imaging models including scar-related regions in electro-anatomical mapping.

Sponsors

CART-Tech.B.V
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient must be willing and able to provide written informed consent - Patient must be >= 18 years old - Patient must have an indication for endocardial VT ablation according to the European Society of Cardiology Guidelines for VT - Presence of a ischemic heart disease

Exclusion criteria

Exclusion criteria: - Contraindications for VT ablation (for example evidence of cardiac thrombi) - Patients with idiopathic VT. - Contraindications to both MRI and MDCT imaging: - MRI: determined using the standard contraindications for MRI as used for clinical purposes, documented allergic reaction to gadolinium. - MDCT: subjects with impaired renal function (severe renal insufficiency, MDRD GFR of

Design outcomes

Primary

MeasureTime frame
To explore the technical performance and safety of scar-related VT ablation using CARTBox-CA platform in patients. * Technical performance will be determined by assessing the relation between the local surface mapping parameters and the local substrate parameters from imaging. * Safety will be established by evaluating (serious) adverse events related to the use of CARTBox-CA.

Secondary

MeasureTime frame
To explore usability of image-guided scar-related substrate mapping using CARTBox-CA software with a questionnaire.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)