ICONIC-M: Improving CRT Outcome With Non-Invasive Cardiac Mapping. A Multicenter Randomized Controlled Study To Assess Patient Response to CRT Comparing ECGI Map Guided Left Ventricular Lead Placement With Empirical Lead Placement

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement. The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation. The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects. The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply: * Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm * There is no trend or reason to believe statistical significance will be reached with a higher sample size. Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Appropriately signed and dated informed consent.

• Age ≥18 years at time of consent.

• Received optimal medical therapy for HF for at least 3 months before screening

• Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteria per ESC CRT guidelines 2013 .

• Patient is intended for placement of a CRT device with biventricular (BiV) pacing.

Locations
Other Locations
Netherlands
Amsterdam University Medical Center
NOT_YET_RECRUITING
Amsterdam
Groningen University Medical Center
NOT_YET_RECRUITING
Groningen
Leids Universitair Medical Center
NOT_YET_RECRUITING
Leiden
Maastricht University Hospital
RECRUITING
Maastricht
Utrecht University Medical Center
NOT_YET_RECRUITING
Utrecht
Portugal
Hospital da Luz
NOT_YET_RECRUITING
Lisbon
Sweden
Lund University Hospital
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
United Kingdom
Bart's Hospital
NOT_YET_RECRUITING
London
King's College
NOT_YET_RECRUITING
London
Oxford University Hospital
NOT_YET_RECRUITING
Oxford
Contact Information
Primary
Matthias Egger, PhD
matthias.egger@ep-solutions.ch
+41 78 659 22 75
Backup
Adrian Maciejewski, Dr
adrian.maciejewski@ep-solutions.ch
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 330
Treatments
Active_comparator: Control
The CRT device is implanted according to clinical practice, without pre-implantation planning. The outcome of the procedure is assessed via echography as per clinical practice.~In addition to clinical practice, the subjects are required to fill in a quality-of-life questionnaire and are subject to an ECG mapping procedure with the Amycard 01C device, including non-contrast CT, to assess the distance between left ventricular lead placement and the latest electrical activation site in the absence of planning information.
Experimental: Active
A pre-implantation ECG mapping with the Amycard 01C device, including CT, is performed prior to the CRT device implantation. The resulting target area for the left ventricular lead placement is communicated to the implanting physician, who will attempt to reach a point close to the target, using the available venous access. At six-month follow-up, response to the therapy is assessed using echocardiography, and a second ECG mapping with Amycard 01C is performed, to assess the distance between actual implantation site and target in the presence of pre-implantation planning information.
Related Therapeutic Areas
Sponsors
Collaborators: QserveCRO
Leads: EP Solutions SA

This content was sourced from clinicaltrials.gov