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Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (CRT-DRIVE)

Primary Purpose

Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment

About this trial

This is an interventional diagnostic trial for Cardiac Resynchronization Therapy focused on measuring Non-invasive activation mapping, Coronary Sinus

Eligibility Criteria

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

Eligible subjects shall meet all following criteria:

Appropriately signed and dated informed consent.
Age ≥18 years at time of consent.
CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I).
Sinus rhythm
QRS duration ≥130 ms
Left bundle branch block
Left ventricular ejection fraction ≤35%
Symptomatic heart failure NYHA class ≥ II
Documented stable medical treatment for at least 6 months
No cardiovascular intervention during the last 6 month

Exclusion Criteria are:

History of persistent or permanent atrial fibrillation
Previous pacemaker or ICD implantation
Indication to pacing due to bradycardia
Patients considered for His bundle pacing or cardiac conduction pacing
Patients with unstable angina
Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment
Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
Subject is implanted with a left ventricular assist device
Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
Subject has congenital heart disease
Subject has a mechanical right-sided heart valve
Subject has a life expectancy of less than one year in the opinion of the investigator
Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
Subject is enrolled in one or more concurrent studies that would confound the results of this study
Patients who have contraindications to CT scanning.
Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT implantation guided by XSpline

Arm Description

The sample size estimation was based on two recent studies including CRT patients with similar clinical and demographic characteristics as in this study: the SMART-MSP and the SMART CRT. The SMART-MSP is a prospective, observational study that enrolled 584 CRT recipients at 52 US sites. In a typical modern CRT population, 75% of patients had a reduction of the end-systolic volume ≥ 15% at 6-month follow-up. The SMART-CRT study enrolled 699 CRT patients randomized to a treatment arm and a control group. At 6-months follow-up, a reduction of LVESV ≥15% was achieved for 67.7% of the patients in the control group and for 74.8% of those in the treatment arm. Therefore, it is assumed that in a modern CRT population at least 70% of the patients will have a reduction of the LVESV ≥15% of the baseline value at 6-months after CRT implantation. To demonstrate that this proportion of patients can be equally achieved with the approach tested in this study at least 150 patients need to be included.

Outcomes

Primary Outcome Measures

Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients

Increase in efficacy of CRT using XSpline technology assessed by reduction of left ventricular end-systolic volume of at least 15% at 6-month follow-up in 75% of CRT treated patients, based on routine echo-cardiographic measurements

Secondary Outcome Measures

Feasibility of systematic use of XSpline platform for CRT implantation

Feasibility of systematic use of automatic cloud-based, AI-based XSpline technology through statistics on software performance (e.g. percentage of core tasks completed higher than defined thresholds)

CRT procedural time difference

Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes

Total X-ray exposure time difference

Evaluate the change in total X-ray exposure time by comparing with standard approach as found in literature, time in minutes

Full Information

NCT ID

NCT05327062

First Posted

March 22, 2022

Last Updated

September 27, 2023

Sponsor

XSpline S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT05327062

Brief Title

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

Acronym

CRT-DRIVE

Official Title

CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 6, 2023 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XSpline S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.

6. Conditions and Keywords

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

Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block

Keywords

Non-invasive activation mapping, Coronary Sinus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The investigation will include 11 European and 5 US investigational sites. The goal is to enroll a total number of 150 patients. It is expected about 1.5 patients per site per month over a period of maximum 8 months after site opening. The study duration is set at 12-month, 6 months for patient enrollment and 6 months of follow-up.

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CRT implantation guided by XSpline

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment

Intervention Description

The following information and data will be obtained from the routine clinical work up of the patients: Patient demographics, cardiovascular medical history, and clinical examination; 12-lead ECG; Standard echocardiography; Computed tomography angiography for visualization of atria, ventricle, and coronary sinus. Imaging data will be transferred to the cloud-based web-platform using a dedicated software provided by study sponsor. Data processing includes evaluating the quality of the data and calculation of various anatomical and electrical parameters, and identification of the target zone as a point in the target vein closest to the latest activation zone. LV-lead location is based on the information provided by the dedicated software followed by visual X-ray based verification of anatomically suitable/most desirable position. The patient will undergo CRT device implantation according to local protocols.

Primary Outcome Measure Information:

Title

Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients

Description

Time Frame

6 months follow-up

Secondary Outcome Measure Information:

Title

Feasibility of systematic use of XSpline platform for CRT implantation

Description

Feasibility of systematic use of automatic cloud-based, AI-based XSpline technology through statistics on software performance (e.g. percentage of core tasks completed higher than defined thresholds)

Time Frame

6 months follow-up

Title

CRT procedural time difference

Description

Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes

Time Frame

6 months follow-up

Title

Total X-ray exposure time difference

Description

Evaluate the change in total X-ray exposure time by comparing with standard approach as found in literature, time in minutes

Time Frame

6 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligible subjects shall meet all following criteria: Appropriately signed and dated informed consent. Age ≥18 years at time of consent. CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I). Sinus rhythm QRS duration ≥130 ms Left bundle branch block Left ventricular ejection fraction ≤35% Symptomatic heart failure NYHA class ≥ II Documented stable medical treatment for at least 6 months No cardiovascular intervention during the last 6 month Exclusion Criteria are: History of persistent or permanent atrial fibrillation Previous pacemaker or ICD implantation Indication to pacing due to bradycardia Patients considered for His bundle pacing or cardiac conduction pacing Patients with unstable angina Subject experienced a recent myocardial infarction, within 40 days prior to enrollment Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year Subject is implanted with a left ventricular assist device Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period) Subject has congenital heart disease Subject has a mechanical right-sided heart valve Subject has a life expectancy of less than one year in the opinion of the investigator Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control Subject is enrolled in one or more concurrent studies that would confound the results of this study Patients who have contraindications to CT scanning. Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2

Central Contact Person:

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

Claudia M Amatruda, PhD

Phone

+390471200372

amatruda@xspline.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angelo Auricchio, MD PhD FESC

Organizational Affiliation

Istituto Cardiocentro Ticino

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Parikshit S Sharma

parikshit_S_Sharma@rush.edu

First Name & Middle Initial & Last Name & Degree

Parikshit S Sharma, MD

Facility Name

The University of Chicago Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gaurav Upadhyay

gupadhyay@medicine.bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Gaurav Upadhyay, MD

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jag Singh

JSINGH@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

William J Hucker, MD, PhD

Facility Name

Duke University Hospital

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Friedman

daniel.friedman@duke.edu

First Name & Middle Initial & Last Name & Degree

Daniel Friedman, MD

Facility Name

Virginia Commonwealth University School of Medicine

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Ellenbogen

kenneth.ellenbogen@vcuhealth.org

First Name & Middle Initial & Last Name & Degree

Kenn Ellenbogen, MD

Facility Name

Ordensklinikum Linz Elisabethinen Hospital

City

Linz

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helmut Puererfellner

helmut.puererfellner@ordensklinikum.at

First Name & Middle Initial & Last Name & Degree

Georgios Kollias, MSc

Facility Name

Semmelweis University

City

Budapest

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bela Merkely

merkely.bela@gmail.com

First Name & Middle Initial & Last Name & Degree

Bela Merkely, PhD DSc FESC

Facility Name

General Hospital of Bolzano

City

Bolzano

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rainer Oberhollenzer

rainer.oberhollenzer@sabes.it

First Name & Middle Initial & Last Name & Degree

Rainer Oberhollenzer, MD

Facility Name

Policlinico Casilino

City

Rome

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leonardo Calò

leonardo.calo@icloud.com

First Name & Middle Initial & Last Name & Degree

Leonardo Calò, MD

Facility Name

Maastricht University Medical Center

City

Maastricht

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin Vernooy

kevin.vernooy@mumc.nl

First Name & Middle Initial & Last Name & Degree

Kevin Vernooy, MD

Facility Name

Univeristat de Barcelona

City

Barcelona

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lluis Mont

lmont@clinic.cat

First Name & Middle Initial & Last Name & Degree

Mont, MD

Facility Name

Istituto Cardiocentro Ticino

City

Lugano

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelo Auricchio

angelo.auricchio@eoc.ch

First Name & Middle Initial & Last Name & Degree

Tardu Özkartal, MD

Facility Name

Queen Elizabeth Hospital

City

Birmingham

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Leyva

cardiologists@hotmail.com

First Name & Middle Initial & Last Name & Degree

Francisco Leyva, MD

Facility Name

King's College Hospital

City

London

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aldo Rinaldi

aldo.rinaldi@kcl.ac.uk

First Name & Middle Initial & Last Name & Degree

Aldo Rinaldi, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34455430

Citation

Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651.

Results Reference

background

Citation

KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl (2011) [Internet] 2013;3(1):163. Available from: https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf

Results Reference

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PubMed Identifier

15034569

Citation

Ramanathan C, Ghanem RN, Jia P, Ryu K, Rudy Y. Noninvasive electrocardiographic imaging for cardiac electrophysiology and arrhythmia. Nat Med. 2004 Apr;10(4):422-8. doi: 10.1038/nm1011. Epub 2004 Mar 14.

Results Reference

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PubMed Identifier

25896779

Citation

Cluitmans MJ, Peeters RL, Westra RL, Volders PG. Noninvasive reconstruction of cardiac electrical activity: update on current methods, applications and challenges. Neth Heart J. 2015 Jun;23(6):301-11. doi: 10.1007/s12471-015-0690-9.

Results Reference

background

PubMed Identifier

33241411

Citation

Pezzuto S, Prinzen FW, Potse M, Maffessanti F, Regoli F, Caputo ML, Conte G, Krause R, Auricchio A. Reconstruction of three-dimensional biventricular activation based on the 12-lead electrocardiogram via patient-specific modelling. Europace. 2021 Apr 6;23(4):640-647. doi: 10.1093/europace/euaa330.

Results Reference

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Citation

Zubarev S, Chmelevsky M, Budanova M, Trukshina M, Lyubimtseva T, Lebedeva V, et al. Non-invasive electrophysiological mapping in assessment of association of cardiac resynchronization effect from position of left ventricular electrode. Europace 2017;19(suppl_3):iii326-iii326. doi: 10.1093/ehjci/eux158.182

Results Reference

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Citation

Zubarev S, Chmelevsky M, Budanova M, Ryzhkov AV, Trukshina M, Lebedeva V, et al. Comparison of the late activation zone and the changes in the structure of the left ventricular myocardium in candidates for cardiac resynchronization therapy. Europace 2018;20(suppl_1):i54-i54. doi: 10.1093/europace/euy015.145

Results Reference

background

PubMed Identifier

23801822

Citation

Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.

Results Reference

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Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

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Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (CRT-DRIVE)

Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial