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New treatment option for Cardiac Resynchronization Therapy
Official title Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
ClinicalTrials.gov ID: NCT05327062
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligible people 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...
- Sinus rhythm
You likely can't join if
- 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
See the full eligibility criteria
- Eligible people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Linz, Austria
- Budapest, Hungary
- Pavia, Pavia, Italy
- Roma, Roma, Italy
- Bolzano, Italy
- Rovereto, Italy
- Maastricht, Netherlands
- Barcelona, Spain
- Lugano, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States; Linz, Austria; Budapest, Hungary; Pavia, Pavia, Italy and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.