Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients (BIO|PULSE)

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

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: BIOTRONIK CRT-D

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 14021
    • Institute for Clinical and Experimental Medicine
  • České Budějovice, Czechia, 37001
    • Ceske Budejovice Hospital
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabetiszentrum NRW
  • Gera, Germany
    • SRH Waldklinikum Gera GmbH
  • Gießen, Germany, 35392
    • Universitätsklinikum Gießen und Marburg
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Netherlands
  • Rotterdam, Netherlands
    • The Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: CRT-D Measurements; Pre-specified measurements and additional follow-ups	Device: BIOTRONIK CRT-D; Pre-specified follow-up and measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Peter Nordbeck, PD Dr., Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2018
• Primary Completion (ACTUAL): June 28, 2018
• Study Completion (ACTUAL): July 6, 2018

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (ACTUAL): October 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: CRT-D, LV Latency
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No