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Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology (NICE CRT)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Device programming
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University InnsbruckRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device programming

Arm Description

according to different settings from the SyncAV algorithm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 30, 2020
Last Updated
April 20, 2022
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT04662970
Brief Title
Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology
Acronym
NICE CRT
Official Title
Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device programming
Arm Type
Experimental
Arm Description
according to different settings from the SyncAV algorithm
Intervention Type
Device
Intervention Name(s)
Device programming
Intervention Description
Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming
Primary Outcome Measure Information:
Title
Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation
Description
The activation time will be measured in 16 different device programming settings
Time Frame
The measurements will be done at Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Dichtl, MD PhD
Phone
004351250481388
Email
dichtl@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Barbieri, MD
Phone
004351250482546
Email
fabian.barbieri@i-med.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Dichtl, MD PhD
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Dichtl, MD PhD
Phone
004351250481388
Email
dichtl@me.com
First Name & Middle Initial & Last Name & Degree
Fabian Barbieri, MD
Phone
00435125048546
Email
fabian.barbieri@i-med.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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