AzTrials
AzTrials

Heart FailureADVISENCT05053568

Image Supported Lead Placement in CRT

A study testing CARTBox in people with Heart Failure, run by UMC Utrecht at 7 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
CARTBox
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
7 sitesNetherlands
Study dates
8 Feb 2021to Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

7 sites in 1 country.

7 sites in 1 country

Netherlands7 sites

  • Amsterdam UMC

    Amsterdam

  • UMC Groningen

    Groningen

  • Maastricht UMC+

    Maastricht

  • St. Antonius Nieuwegein

    Nieuwegein

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD

  • UMC Utrecht

    Utrecht

  • Isala Zwolle

    Zwolle

Other trials in Netherlands

About this study

Official title: Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

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
Being tested
CARTBox
Keywords
Cardiac Resynchronization Therapy, Image-guided therapy, Lead placement, MRI
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CARTBoxDevice

    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.

Study groups in NCT05053568
Study groupRoleWhat they receive
Intervention groupExperimentalLive visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments.
Receives: Device: CARTBox
Control groupNo interventionEmpirical standard-of-care left ventricular lead placement, in line with current CRT implantation guidelines with electrical guiding on the basis of Q-LV sense.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in % of patients with succesfull LV lead location

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

    Measured: Direct post-CRT

Secondary outcomes (5)

  1. 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%.

    Measured: 6 months

  2. Change in EQ-5D-5L

    A quality of life questionnaire

    Measured: 6, 12 and 24 months

  3. Change in Kansas City Cardiomyopathy Questionnaire

    A quality of life questionnaire

    Measured: 6, 12 and 24 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start8 Feb 2021
  3. Primary completion1 Oct 2023
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053568
Sponsor's protocol ID
NL73416.041.20
Other IDs
404460098327, LSHM191o3-Ho7o
Acronym
ADVISE
Status last verified
Mar 2025
First submitted
27 Aug 2021
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Within legal and ethical limits, deidentified individual clinical trial participant-level data (IPD), generated by our research, can be made available. Upon publication, data will be made available upon reasonable request and in agreement with a collaboration agreement. A data sharing and management plan is provided.

Publications

  • 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.

    PubMed 36713038

  • 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.

    PubMed 34697125

  • 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.

    PubMed 40117420

Questions about this trial

What is this clinical trial studying?

A study testing CARTBox in people with Heart Failure, run by UMC Utrecht at 7 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in % of patients with succesfull LV lead location (time frame: Direct post-CRT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05053568, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Image Supported Lead Placement in CRT (NCT05053568) | AzTrials