Image Supported Lead Placement in CRT

NCT05053568 | Active Not Recruiting

• 3 other identifiers: NL73416.041.20404460098327LSHM191o3-Ho7o
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy; Image-guided therapy; Lead placement; MRI

Outcome Measures

Primary Outcomes (1)

• Differences in % of patients with succesfull LV lead location

  Lead location, defined as being within, adjacent, or remote from the pre-defined target.

  Direct post-CRT

Secondary Outcomes (5)

• Change in reverse remodelling and volumetric response

  6 months

• Change in EQ-5D-5L

  6, 12 and 24 months

• Change in Kansas City Cardiomyopathy Questionnaire

  6, 12 and 24 months

• Change in CRT response score

  12 months

• Health Technology Assessment

  24 months

Other Outcomes (8)

• Difference in total implantation procedure time.

  Direct post-CRT

• Difference in total fluoroscopy time during procedure.

  Direct post-CRT

• Difference in total contrast dose used during procedure.

  Direct post-CRT

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: CARTBox

Control group

NO INTERVENTION

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.

Interventions

CARTBox DEVICE

CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• CART-Tech B.V.: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Health Holland: collaborator

Study Sites (7)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

St. Antonius Nieuwegein

Nieuwegein, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Isala Zwolle

Zwolle, Netherlands

Location

Related Publications (3)

• Wouters PC, van Slochteren FJ, Tuinenburg AE, Doevendans PA, Cramer MM, Delnoy PHM, van Dijk VF, Meine M. On-screen image-guided lead placement in cardiac resynchronization therapy: Feasibility and outcome in a multicenter setting. Heart Rhythm O2. 2022 Oct 18;4(1):9-17. doi: 10.1016/j.hroo.2022.10.002. eCollection 2023 Jan.

  PMID: 36713038 BACKGROUND

• Wouters PC, van Lieshout C, van Dijk VF, Delnoy PH, Doevendans PA, Cramer MJ, Frederix GW, van Slochteren FJ, Meine M. Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation. BMJ Open. 2021 Oct 25;11(10):e054115. doi: 10.1136/bmjopen-2021-054115.

  PMID: 34697125 BACKGROUND

• Gerrits W, Wouters PC, Chiu CSL, Guglielmo M, Cramer MJ, van der Harst P, Vernooy K, van Stipdonk AMW, van Halm VP, van Dijk VF, Ghani A, Maass AH, Yap SC, van Slochteren FJ, Meine M. Optimizing CRT Lead Placement Accuracy With CMR-Guided On-Screen Targeting: A Randomized Controlled Trial (ADVISE-CRT III). JACC Clin Electrophysiol. 2025 Jun;11(6):1293-1305. doi: 10.1016/j.jacep.2025.01.022. Epub 2025 Mar 19.

  PMID: 40117420 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mathias Meine, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MD, PhD)

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 22, 2021
• Study Start: February 8, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

NL (7)