Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy (ADVISE-CRT II trial)

Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy (ADVISE-CRT II trial) - ADVISE-CRT II trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49313

Enrollment

Registered

2019-09-12

Start date

2019-12-05

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Cardiomyopathy heart failure

Interventions

CRT procedure (conventional), but carried out under guidance of CARTBox software (new)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: An indication for cardiac resynchronization therapy according to the current international evidence based guidelines for CRT (the 2013 European Society of Cardiology Guidelines for cardiac pacing and cardiac resynchronization therapy) - Chronic heart failure; - New York Heart Association functional class II, III, IV (ambulatory); - QRS duration *120ms; - Optimal pharmacological therapy; - Left ventricular ejection fraction *35%;

Exclusion criteria

Exclusion criteria: - Contraindications for implantation of a CRT device; - Age

Design outcomes

Primary

Measure	Time frame
Safety: radiation dose during the procedure, (serious) adverse events. Efficacy: LV lead implantation within target (yes/no).	—

Secondary

Measure	Time frame
Long-term efficacy: LV end systolic volume reduction assessed by echocardiography at 6 months after the CRT implantation. Feasibility: overall CRT implantation procedure duration, time to perform the placement of the LV lead, preparation time in the Cath lab. Radiation time during the procedure. Validation of 2D image registration compared to 3D image registration. Software usability and feasibility of CARTBox during the lead placement (questionnaire for the operator on the use of CARTBox before and during the LV lead implantation). Measures of acute electrical synchronization (QRS duration, QLVs). Total cost of procedure and healthcare costs, using a Health Technology Assessment (HTA) approach (in cooperation with Julius Clinical, UMC Utrecht). Number of LV leads used, number of LV lead repositioning procedures.	—

Measure

Time frame

Long-term efficacy: LV end systolic volume reduction assessed by echocardiography at 6 months after the CRT implantation. Feasibility: overall CRT implantation procedure duration, time to perform the placement of the LV lead, preparation time in the Cath lab. Radiation time during the procedure. Validation of 2D image registration compared to 3D image registration. Software usability and feasibility of CARTBox during the lead placement (questionnaire for the operator on the use of CARTBox before and during the LV lead implantation). Measures of acute electrical synchronization (QRS duration, QLVs). Total cost of procedure and healthcare costs, using a Health Technology Assessment (HTA) approach (in cooperation with Julius Clinical, UMC Utrecht). Number of LV leads used, number of LV lead repositioning procedures.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)