Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients

NCT ID: NCT03314675

Last Updated: 2018-11-28

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

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2018-07-06

Brief Summary

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The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data

Detailed Description

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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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CRT-D Measurements

Pre-specified measurements and additional follow-ups

Group Type OTHER

BIOTRONIK CRT-D

Intervention Type DEVICE

Pre-specified follow-up and measurements

Interventions

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BIOTRONIK CRT-D

Pre-specified follow-up and measurements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
* Patient successfully implanted with a left ventricular lead
* High likelihood of LV latency ≥ 40 ms
* LV lead in lateral or postero-lateral position in the coronary venous system
* Patient is able to understand the nature of the clinical investigation
* Patient is willing to undergo the required measurements at the investigation site
* Patient provides written informed consent
* Age ≥ 18 years

Exclusion Criteria

* Patients with irregular ventricular rhythm due to atrial tachycardia
* Pregnant or breast-feeding women
* Participation in an interventional clinical investigation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Nordbeck, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

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Ceske Budejovice hospital

České Budějovice, , Czechia

Site Status

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Herz- und Diabetiszentrum NRW

Bad Oeynhausen, , Germany

Site Status

SRH Waldklinikum Gera GmbH

Gera, , Germany

Site Status

Universitätsklinikum Gießen und Marburg

Giessen, , Germany

Site Status

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status

The Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Czechia Germany Netherlands

Other Identifiers

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CR022

Identifier Type: -

Identifier Source: org_study_id

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