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Active, Not Recruiting

NCT Number: NCT05053568

Image Supported Lead Placement in CRT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC, Rotterdam, South Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Direct post-CRT

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

Secondary outcomes

  1. Change in reverse remodelling and volumetric response

    Time frame: 6 months

    Measured as the relative decrease in LV end-systolic volume, indexed to body surface area (LVESVi). Response defined as LVESVi-reduction ≥ 15%.

  2. Change in EQ-5D-5L

    Time frame: 6, 12 and 24 months

    A quality of life questionnaire

  3. Change in Kansas City Cardiomyopathy Questionnaire

    Time frame: 6, 12 and 24 months

    A quality of life questionnaire

  4. Change in CRT response score

    Time frame: 12 months

    A hierarchical clinical endpoints, combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up.

  5. Health Technology Assessment

    Time frame: 24 months

    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.

Other outcomes

  1. Difference in total implantation procedure time.

    Time frame: Direct post-CRT

    Compared between both groups. Measured in minutes.

  2. Difference in total fluoroscopy time during procedure.

    Time frame: Direct post-CRT

    Compared between both groups. Measured in minutes.

  3. Difference in total contrast dose used during procedure.

    Time frame: Direct post-CRT

    Compared between both groups. Measured in dose area product.

  4. Difference in change in QRS duration

    Time frame: Direct post-CRT and 6 months

    Compared between groups and according to LV lead location. Measured in ms.

  5. Difference in change in QRSarea

    Time frame: Direct post-CRT and 6 months

    Compared between groups and according to LV lead location. Measured in μVs.

  6. Difference in Q-LV sense

    Time frame: Direct post-CRT

    Compared between groups and according to LV lead location. Measured in ms.

  7. Difference in pacing threshold

    Time frame: Direct post-CRT

    Compared between groups and according to LV lead location. Measured in mV.

  8. Difference in % of patients with disappearance of apical rocking

    Time frame: Direct post-CRT and 6 months

    Compared between groups and according to LV lead location. Option to assess other indices of mechanical recoordination.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

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

Registry information

Official study title

Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Acronym: ADVISE

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Sep 22, 2021
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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