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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05327062
Other study ID # CRT-DRIVE_01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 6, 2023
Est. completion date September 2024

Study information

Verified date February 2024
Source XSpline S.p.A.
Contact Claudia M Amatruda, PhD
Phone +390471200372
Email amatruda@xspline.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Ordensklinikum Linz Elisabethinen Hospital Linz
Hungary Semmelweis University Budapest
Italy General Hospital of Bolzano Bolzano
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy University Tor Vergata Roma
Italy Ospedale S. Maria del Carmine di Rovereto Rovereto
Netherlands Maastricht University Medical Center Maastricht
Spain Univeristat de Barcelona Barcelona
Switzerland Istituto Cardiocentro Ticino Lugano
United States Massachusetts General Hospital Boston Massachusetts
United States Rush University Medical center Chicago Illinois
United States The University of Chicago Medicine Chicago Illinois
United States Duke University Hospital Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
XSpline S.p.A.

Countries where clinical trial is conducted

United States,  Austria,  Hungary,  Italy,  Netherlands,  Spain,  Switzerland, 

References & Publications (8)

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. — View 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. — View 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. — View 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

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. — View 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. — View 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

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months follow-up
Secondary 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) 6 months follow-up
Secondary CRT procedural time difference Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes 6 months follow-up
Secondary 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 6 months follow-up
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