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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (4)

IL

MA

NC