Image Supported Lead Placement in CRT

Heart Failure Clinical Trial

— ADVISE  

Official title:

Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053568
• Other study ID #: NL73416.041.20
• Secondary ID: 404460098327LSHM
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: February 2025

Study information

• Verified date: September 2021
• Source: UMC Utrecht
• Contact: Mathias Meine, MD, PhD
• Phone: +31887574099
• Email: m.meine[@]utrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 2025
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CARTBox
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	UMC Groningen	Groningen
Netherlands	Maastricht UMC+	Maastricht
Netherlands	St. Antonius Nieuwegein	Nieuwegein
Netherlands	UMC Utrecht	Utrecht
Netherlands	Isala Zwolle	Zwolle

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	CART-Tech B.V., Health Holland, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in total implantation procedure time.	Compared between both groups. Measured in minutes.	Direct post-CRT
Other	Difference in total fluoroscopy time during procedure.	Compared between both groups. Measured in minutes.	Direct post-CRT
Other	Difference in total contrast dose used during procedure.	Compared between both groups. Measured in dose area product.	Direct post-CRT
Other	Difference in change in QRS duration	Compared between groups and according to LV lead location. Measured in ms.	Direct post-CRT and 6 months
Other	Difference in change in QRSarea	Compared between groups and according to LV lead location. Measured in µVs.	Direct post-CRT and 6 months
Other	Difference in Q-LV sense	Compared between groups and according to LV lead location. Measured in ms.	Direct post-CRT
Other	Difference in pacing threshold	Compared between groups and according to LV lead location. Measured in mV.	Direct post-CRT
Other	Difference in % of patients with disappearance of apical rocking	Compared between groups and according to LV lead location. Option to assess other indices of mechanical recoordination.	Direct post-CRT and 6 months
Primary	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	Change in reverse remodelling and volumetric response	Measured as the relative decrease in LV end-systolic volume, indexed to body surface area (LVESVi). Response defined as LVESVi-reduction = 15%.	6 months
Secondary	Change in EQ-5D-5L	A quality of life questionnaire	6, 12 and 24 months
Secondary	Change in Kansas City Cardiomyopathy Questionnaire	A quality of life questionnaire	6, 12 and 24 months
Secondary	Change in CRT response score	A hierarchical clinical endpoints, combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up.	12 months
Secondary	Health Technology Assessment	The value of image-guided lead placement will be investigated in terms of healthcare expenditure revolving heart failure care. This assesment will be based on a previously conducted preliminary economic analysis.	24 months