Image Supported Lead Placement in CRT (ADVISE)

UMC Utrecht

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: CARTBox

Study type: Interventional

Funder types: Other

Identifiers

NCT05053568

404460098327 (Other Grant/Funding Number)

LSHM191o3-Ho7o (Other Grant/Funding Number)

NL73416.041.20

Details and patient eligibility

About

Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart failure with LV ejection fraction ≤ 35%;
• New York Heart Association class II, III, or IV (ambulatory);
• Optimal medical treatment that is tolerable;
• Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms.

Exclusion criteria

• Pregnancy or lactation;
• Subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
• Atrial fibrillation or atrial fibrillation during MRI
• Documented allergic reaction to gadolinium;
• Impossibility to undergo an MRI scan;
• Participation in another clinical study that prohibits any procedures other than standard.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Intervention group

Experimental group

Description:

Live visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments.

Treatment:

Device: CARTBox

Control group

No Intervention group

Description:

Empirical standard-of-care left ventricular lead placement, in line with current CRT implantation guidelines with electrical guiding on the basis of Q-LV sense.