Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy (CCI impact)

University of Oslo (UIO)

Status

Completed

Conditions

Resynchronization Therapy

Heart Failure

Assessment of Acute CRT Response

Treatments

Procedure: Cardiac resynchronization therapy device implantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01996397

2013/140

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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