Boston, MANCT05327062Now EnrollingIRB Ready

Cardiac Resynchronization Therapy Clinical Trial in Boston, MA

Access cutting-edge cardiac resynchronization therapy treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by XSpline S.p.A.

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in Boston

Access cardiac resynchronization therapy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cardiac resynchronization therapy treatment provided free

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Check if you qualify for this cardiac resynchronization therapy clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Cardiac Resynchronization Therapy Study in Boston

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.

Sponsor: XSpline S.p.A.

Who Can Participate

Inclusion 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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05327062) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cardiac Resynchronization Therapy Treatment Options in Boston, MA

If you're searching for cardiac resynchronization therapy treatment options in Boston, MA, this clinical trial (NCT05327062) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cardiac resynchronization therapy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cardiac resynchronization therapy clinical trials near you to find additional studies recruiting in your area.

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