Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment

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

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-21

Study Completion Date

2020-02-27

Brief Summary

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Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment

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Detailed Description

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Conditions

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Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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standard BIV

the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes.

No interventions assigned to this group

MPP BIV

Such modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation.

Cardiac Resynchronization Therapy device programming

Intervention Type DEVICE

Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively

Interventions

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Cardiac Resynchronization Therapy device programming

Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines

Exclusion Criteria

* Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF
* NYHA IV patients
* Right Bundle Branch Block

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No