Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology

Heart Failure Clinical Trial

— NICE CRT  

Official title:

Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662970
• Other study ID #: Version 1.2, 09.07.2019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Medical University Innsbruck
• Contact: Wolfgang Dichtl, MD PhD
• Phone: 004351250481388
• Email: dichtl[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology

Description:

Patient specific anatomic parameters taken from the cardiac magnetic resonance examination will be the base for a semiautomatic model incorporating the conductivity of the heart, the lungs, blood and the torso. For this reason, a software package (AMIRA Developer, TGS Template Graphics Software, France) has been adapted to calculate a quasi static approximation of Maxwell equations.

After fusion of the T1 CMR scan and the ECG electrodes a model-based bidomain FEM is used for a step-wise measurement of the local activation times (resting potential: 290 mV; plateau: 0 mV; acceleration time: 3 ms) both Ende- and epicardially.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software

• left bundle branch block before CRT implantation

• PQ interval = 250 ms before implantation

Exclusion Criteria:

• high-grade AV block

• any contraindication concerning a safe CMR performance including claustrophobia

• terminal heart failure (NYHA IV) or cardiac decompensation

• life expectancy < 1 year

• women with child-bearing potential, pregnancy

• drug abusus

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Device programming
Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation	The activation time will be measured in 16 different device programming settings	The measurements will be done at Day 1