Cardiac Resynchronization TherapyCRT-DRIVENCT05327062
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
A study testing CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment in people with Cardiac Resynchronization Therapy and Chronic Heart Failure, run by XSpline S.p.A. at 13 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- What is being tested?
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 6 Mar 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
United States4 sites, 4 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jag Singh, JSINGH@mgh.harvard.edu
William J Hucker, MD, PhD
- Not yet recruiting
Rush University Medical center
Chicago, Illinois, 60637
Parikshit S Sharma, parikshit_S_Sharma@rush.edu
Parikshit S Sharma, MD
- Not yet recruiting
The University of Chicago Medicine
Chicago, Illinois, 60637
Gaurav Upadhyay, gupadhyay@medicine.bsd.uchicago.edu
Gaurav Upadhyay, MD
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Daniel Friedman, daniel.friedman@duke.edu
Daniel Friedman, MD
Italy4 sites, 4 recruiting
- Not yet recruiting
General Hospital of Bolzano
Bolzano
Rainer Oberhollenzer, rainer.oberhollenzer@sabes.it
Rainer Oberhollenzer, MD
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia
Roberto Rordorf, MD, R.Rordorf@smatteo.pv.it
- Not yet recruiting
University Tor Vergata
Roma, Roma
Claudia Tamburro, MD, claudia.tamburro96@gmail.com
- Not yet recruiting
Ospedale S. Maria del Carmine di Rovereto
Rovereto
Maurizio del Greco, MD, maurizio.delgreco@apss.tn.it
Austria1 site, 1 recruiting
- Recruiting
Ordensklinikum Linz Elisabethinen Hospital
Linz
Helmut Puererfellner, helmut.puererfellner@ordensklinikum.at
Georgios Kollias, MSc
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University
Budapest
Bela Merkely, merkely.bela@gmail.com
Bela Merkely, PhD DSc FESC
Netherlands1 site, 1 recruiting
- Not yet recruiting
Maastricht University Medical Center
Maastricht
Kevin Vernooy, kevin.vernooy@mumc.nl
Kevin Vernooy, MD
Spain1 site, 1 recruiting
- Recruiting
Univeristat de Barcelona
Barcelona
Lluis Mont, lmont@clinic.cat
Mont, MD
Switzerland1 site, 1 recruiting
- Recruiting
Istituto Cardiocentro Ticino
Lugano
Angelo Auricchio, angelo.auricchio@eoc.ch
Tardu Özkartal, MD
About this study
Official title: CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
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.
- Being tested
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Keywords
- Non-invasive activation mapping, Coronary Sinus
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CRT implantation guided by XSpline | Experimental | 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. Receives: Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months follow-up
Secondary outcomes (3)
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)
Measured: 6 months follow-up
CRT procedural time difference
Evaluate the change in CRT procedural time by comparing with standard approach as found in literature, time in minutes
Measured: 6 months follow-up
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
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start6 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigation will include 9 European and 4 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XSpline S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelo Auricchio, MD PhD FESC, Principal investigator, Istituto Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327062
- Sponsor's protocol ID
- CRT-DRIVE_01
- Acronym
- CRT-DRIVE
- Status last verified
- Oct 2024
- First submitted
- 22 Mar 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34455430KDIGO 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
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.
PubMed 15034569Cluitmans 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.
PubMed 25896779Pezzuto 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.
PubMed 33241411Zubarev 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
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
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.
PubMed 23801822
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
- ClinicalTrials.gov ID
- NCT05327062
- Acronym / sponsor ID
- CRT-DRIVE / CRT-DRIVE_01
- Keywords
- Non-invasive activation mapping, Coronary Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- XSpline S.p.A.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigation will include 9 European and 4 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.
| Arm | Type | Receives |
|---|---|---|
| CRT implantation guided by XSpline | Experimental | Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessmentThe 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. | Device | CRT implantation guided by XSpline |
Primary outcome
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
Time frame: 6 months follow-up
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
3 secondary outcomes
Feasibility of systematic use of XSpline platform for CRT implantation
Time frame: 6 months follow-up
CRT procedural time difference
Time frame: 6 months follow-up
Total X-ray exposure time difference
Time frame: 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 34455430Glikson 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.
- BackgroundKDIGO 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
- Background: PubMed 15034569Ramanathan 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.
- Background: PubMed 25896779Cluitmans 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.
- Background: PubMed 33241411Pezzuto 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.
- BackgroundZubarev 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
- BackgroundZubarev 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
- Background: PubMed 23801822Brignole 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Auricchio, MD PhD FESC principal investigator
Istituto Cardiocentro Ticino
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment in people with Cardiac Resynchronization Therapy and Chronic Heart Failure, run by XSpline S.p.A. at 13 sites in 7 countries.
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 0 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Italy, Austria, Hungary, Netherlands and 2 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia M Amatruda, PhD (+390471200372, amatruda@xspline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients (time frame: 6 months follow-up). 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 NCT05327062, which also lists 8 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 24 Oct 2024.