Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy

NCT ID: NCT03640000

Last Updated: 2018-08-21

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

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-12-31

Brief Summary

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This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.

Detailed Description

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Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.

Conditions

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Heart Failure, Systolic

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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Determination of impedance signals

This single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements.

Group Type EXPERIMENTAL

Impedance measurements in Cardiac Resynchronization therapy

Intervention Type DIAGNOSTIC_TEST

Bioimpedance measurements

Interventions

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Impedance measurements in Cardiac Resynchronization therapy

Bioimpedance measurements

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hans Henrik Odland

principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Henrik Odland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Hans Henrik Odland, MD, PhD

Role: CONTACT

23070000 ext. +47

Facility Contacts

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Hans Henrik Odland

Role: primary

Other Identifiers

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2014/1223

Identifier Type: -

Identifier Source: org_study_id

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