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

Not Applicable

Terminated

• Conditions: Heart Failure
• Interventions: Device: BIOTRONIK CRT-D

• Registration Number: NCT03314675
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Study Start: 2018-02-26
• Primary Completion: 2018-06-28
• Study Completion: 2018-07-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT-D Measurements	BIOTRONIK CRT-D	Pre-specified measurements and additional follow-ups

Primary Outcome Measures

Name	Time	Method
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients	1 day

Secondary Outcome Measures

Name	Time	Method
Device-base measured LV latency in the LV IEGM channel and Far Field channel	1 day
12-lead ECG-measured LV latency in the channel with earliest QRS onset	1 day
Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel	1 day
12-lead ECG-measured latency intervals	1 day

Trial Locations

Locations (7)

Institute for Clinical and Experimental Medicine; 🇨🇿 Praha, Czechia

SRH Waldklinikum Gera GmbH; 🇩🇪 Gera, Germany

Ceske Budejovice hospital; 🇨🇿 České Budějovice, Czechia

Universitätsklinikum Gießen und Marburg; 🇩🇪 Gießen, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

The Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Herz- und Diabetiszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany