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Clinical Trials/NCT04662970
NCT04662970
Recruiting
N/A

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

Medical University Innsbruck1 site in 1 country25 target enrollmentJanuary 1, 2020
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Medical University Innsbruck
Enrollment
25
Locations
1
Primary Endpoint
Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation
Status
Recruiting
Last Updated
7 months ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 31, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medical University Innsbruck
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation

Time Frame: The measurements will be done at Day 1

The activation time will be measured in 16 different device programming settings

Study Sites (1)

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