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

NCT ID: NCT04662970

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Device programming

according to different settings from the SyncAV algorithm

Group Type EXPERIMENTAL

Device programming

Intervention Type DEVICE

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

Interventions

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Device programming

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Dichtl, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Wolfgang Dichtl, MD PhD

Role: CONTACT

004351250481388

Fabian Barbieri, MD

Role: CONTACT

004351250482546

Facility Contacts

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Wolfgang Dichtl, MD PhD

Role: primary

004351250481388

Fabian Barbieri, MD

Role: backup

00435125048546

Other Identifiers

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Version 1.2, 09.07.2019

Identifier Type: -

Identifier Source: org_study_id

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