Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response

NCT ID: NCT03141606

Last Updated: 2019-08-01

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

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-02-29

Brief Summary

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Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset

Detailed Description

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Conditions

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Left Atrial Volume

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
* Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration \>= 120 ms
* Patients who will undergo to a new CRT-defibrillator system implantation
* Patients who are able to understand and sign the informed consent
* Patients who are able to attend all required follow-up visits at the study centerfor 24 months

Exclusion Criteria

* Age \< 18 years
* Women who are pregnant or who are planning to become pregnant
* Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
* Patients with organic mitral valve disease
* Patients with prosthetic heart valves
* Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart transplantation, patients with CRT devices
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Borgo Trento - Verona

OTHER

Sponsor Role lead

Responsible Party

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Dr. Giovanni Morani

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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G. Panico Hospital

Tricase, Italy/Lecce, Italy

Site Status RECRUITING

Borgo Trento Hospital

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Pietro Palmisano

Role: primary

Giovanni Morani

Role: primary

045 812 1111

Other Identifiers

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20140002277

Identifier Type: -

Identifier Source: org_study_id

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