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Image Supported Lead Placement in CRT (ADVISE)

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

CARTBox

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Image-guided therapy, Lead placement, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Amsterdam UMC
UMC Groningen
Maastricht UMC+
St. Antonius NieuwegeinRecruiting
UMC UtrechtRecruiting
Isala ZwolleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Differences in % of patients with succesfull LV lead location

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

Secondary Outcome Measures

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%.

Change in EQ-5D-5L

A quality of life questionnaire

Change in Kansas City Cardiomyopathy Questionnaire

A quality of life questionnaire

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.

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.

Full Information

NCT ID

NCT05053568

First Posted

August 27, 2021

Last Updated

September 13, 2021

Sponsor

UMC Utrecht

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05053568

Brief Title

Image Supported Lead Placement in CRT

Acronym

ADVISE

Official Title

Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

CARTBox

Intervention Description

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 Outcome Measure Information:

Title

Differences in % of patients with succesfull LV lead location

Description

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

Time Frame

Direct post-CRT

Secondary Outcome Measure Information:

Title

Change in reverse remodelling and volumetric response

Description

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

Time Frame

6 months

Title

Change in EQ-5D-5L

Description

A quality of life questionnaire

Time Frame

6, 12 and 24 months

Title

Change in Kansas City Cardiomyopathy Questionnaire

Description

A quality of life questionnaire

Time Frame

6, 12 and 24 months

Title

Change in CRT response score

Description

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

Time Frame

12 months

Title

Health Technology Assessment

Description

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

Difference in total implantation procedure time.

Description

Compared between both groups. Measured in minutes.

Time Frame

Direct post-CRT

Title

Difference in total fluoroscopy time during procedure.

Description

Compared between both groups. Measured in minutes.

Time Frame

Direct post-CRT

Title

Difference in total contrast dose used during procedure.

Description

Compared between both groups. Measured in dose area product.

Time Frame

Direct post-CRT

Title

Difference in change in QRS duration

Description

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

Time Frame

Direct post-CRT and 6 months

Title

Difference in change in QRSarea

Description

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

Time Frame

Direct post-CRT and 6 months

Title

Difference in Q-LV sense

Description

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

Time Frame

Direct post-CRT

Title

Difference in pacing threshold

Description

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

Time Frame

Direct post-CRT

Title

Difference in % of patients with disappearance of apical rocking

Description

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

Time Frame

Direct post-CRT and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mathias Meine, MD, PhD

Phone

+31887574099

m.meine@utrecht.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Wouters, MD

Phone

+31887574375

p.wouters@umcutrecht.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathias Meine, MD, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

Amsterdam UMC

City

Amsterdam

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vokko van Halm, MD, PhD

Facility Name

UMC Groningen

City

Groningen

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Maass, MD, PhD

Facility Name

Maastricht UMC+

City

Maastricht

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin Vernooy, MD, PhD

Facility Name

St. Antonius Nieuwegein

City

Nieuwegein

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent van Dijk, MD, PhD

Facility Name

UMC Utrecht

City

Utrecht

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathias Meine, MD, PhD

Facility Name

Isala Zwolle

City

Zwolle

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Paul Delnoy, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

34697125

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.

Results Reference

derived

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Image Supported Lead Placement in CRT

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