ICONIC-M: IMPROVING CRT OUTCOME WITH NON-INVASIVE CARDIAC MAPPING;A multicentre randomised controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empiric lead placement.

Conditions: cardiac arrhythmia
Heart Failure
10019280

Registration Number: NL-OMON53972

Lead Sponsor: EP Solutions SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 186

Inclusion Criteria

Eligible subjects must meet all of the following criteria to be included in the
study:

1. Appropriately signed and dated informed consent.
2. Age >=18 years at time of consent.
3. Considered stabilized after >=3 months of optimal medical therapy before
screening
4. Patient in Sinus Rhythm at the time of screening, having LBBB per ESC
guidelines 2013.
a. QRS duration >=120ms
b. QS or rS in lead V1
c. Broad (frequently notched or slurred) R waves in leads I, aVL, V5, or V6
d. Absent Q waves in leads V5 and V6
5. Patient is intended for placement of a CRT device with biventricular (BiV)
pacing.

Exclusion Criteria

Subjects that meet any of the following criteria will be excluded from the
study: 1. Currently implanted with pacemaker or ICD with >20% RV pacing in the
past 3 months. 2. Acute diseases or exacerbations of chronic diseases (as per
the investigator*s discretion) 3. Contraindications to CT-scanning 4.
Contraindications to body surface ECG mapping: o ongoing wound healing on the
chest (e.g. recent surgery) o skin diseases o allergic reactions to surface
mapping electrodes and medical band-aid 5. Pregnant, or subjects planning to
become pregnant within 24 months after signing informed consent o A documented
negative pregnancy test (serum or blood) is required for women of childbearing
potential. 6. Incapacitated individuals, defined as persons who are mentally
ill, mentally handicapped, or individuals without legal authority, are excluded
from the study population

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this investigation are:<br /><br>• Left Ventricular End-Systolic Volume index (LVESVi) (mL/m2) mean reduction of<br /><br>additional >=30% (active arm) compared to empiric CRT LV lead implantation<br /><br>(control arm) at 6 months post-implantation versus baseline measured by<br /><br>transthoracic echocardiography.<br /><br>• The proportion of patients in the ECGI map-guided (active) arm having a<br /><br>distance from the active pole of the LV lead to LV LEAS at 6 months follow-up <=<br /><br>47 mm being significantly higher than in the non-guided (empiric lead<br /><br>placement) arm (control arm).</p><br>

Secondary Outcome Measures