Clinical trial NCT05053568: Image Supported Lead Placement in CRT
Official title: Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy
Image-guided therapy
Lead placement
MRI
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: CART-Tech B.V.
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Health Holland
First posted: 2021-09-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in % of patients with succesfull LV lead location
timeFrame: Direct post-CRT
Secondary outcomes:
measure: Change in reverse remodelling and volumetric response
timeFrame: 6 months
measure: Change in EQ-5D-5L
timeFrame: 6, 12 and 24 months
measure: Change in Kansas City Cardiomyopathy Questionnaire
timeFrame: 6, 12 and 24 months
measure: Change in CRT response score
timeFrame: 12 months
measure: Health Technology Assessment
timeFrame: 24 months
Other outcomes:
measure: Difference in total implantation procedure time.
timeFrame: Direct post-CRT
measure: Difference in total fluoroscopy time during procedure.
timeFrame: Direct post-CRT
measure: Difference in total contrast dose used during procedure.
timeFrame: Direct post-CRT
measure: Difference in change in QRS duration
timeFrame: Direct post-CRT and 6 months
measure: Difference in change in QRSarea
timeFrame: Direct post-CRT and 6 months
measure: Difference in Q-LV sense
timeFrame: Direct post-CRT
measure: Difference in pacing threshold
timeFrame: Direct post-CRT
measure: Difference in % of patients with disappearance of apical rocking
timeFrame: Direct post-CRT and 6 months
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nieuwegein
country: Netherlands
facility: St. Antonius Nieuwegein
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala Zwolle
Study officials:
affiliation: UMC Utrecht
name: Mathias Meine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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 Mar 3:S2405-500X(25)00081-7. doi: 10.1016/j.jacep.2025.01.022. Online ahead of print.