Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy

Study Overview
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Brief Summary
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Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.

Official Title
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Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy

Conditions
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Heart Failure, Resynchronization Therapy, Assessment of Acute CRT Response

Intervention / Treatment
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* Procedure: Cardiac resynchronization therapy device implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is indicated for CRT or CRT-D device according to current applicable ESC/AHA guidelines Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). No documented AF-episodes allowed during the last 2 weeks prior to inclusion. Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment. Subject (or the legal guardian) is willing to sign informed consent form Exclusion Criteria: Permanent atrial fibrillation/ flutter or tachycardia RBBB Recent myocardial infarction (MI), within 40 days prior to enrollment. Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment 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 Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year On chronic renal dialysis, or with severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2) On continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week) Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period) Complex and uncorrected congenital heart disease Mechanical heart valve Breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control Enrolled in one or more concurrent studies that would confound the results of this study Already implanted with pacemaker (CRT, CRT-D, ICD) and needs replacement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CRT implantation<br>Standard CRT indication. Assessment of acute response to CRT. | Procedure: Cardiac resynchronization therapy device implantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dP\dt max response to different ventricular lead pacing sites | To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead movements and electrical measures | Compare metrics derived from 2/3-D reconstructions of lead movement to electrical measures (e.g. Q-LV-timing or VCG) at different pacing configurations in patients undergoing a CRT-implant. | 6 months | 
| Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation | To compare metrics derived from 2/3-D reconstructions of lead movement to Force-Interval-Relation at different pacing configurations in patients undergoing a CRT-implant. | 6 months | 
| Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map | To compare metrics derived from 2/3-D reconstructions of lead movement to CardioGuide Motion Map at different pacing configurations in patients undergoing a CRT-implant. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Bundle branch block, CRT response