Improving CRT Outcome With Non-Invasive Cardiac Mapping
Recruiting
N/A
Interventional Study
Heart Failure With Reduced Ejection Fraction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 330 (estimated)
- Sponsor
- EP Solutions SA · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Appropriately signed and dated informed consent.
2. Age ≥18 years at time of consent.
3. Received optimal medical therapy for HF for at least 3 months before screening
4. Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteria per ESC CRT guideline…
Contacts