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

Heart Failure Clinical Trial

— BIO|PULSE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03314675
• Other study ID #: CR022
• Status: Terminated
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: November 2018
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: July 6, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• BIOTRONIK CRT-D
Pre-specified follow-up and measurements

Locations

Country	Name	City	State
Czechia	Ceske Budejovice hospital	Ceské Budejovice
Czechia	Institute for Clinical and Experimental Medicine	Praha
Germany	Herz- und Diabetiszentrum NRW	Bad Oeynhausen
Germany	SRH Waldklinikum Gera GmbH	Gera
Germany	Universitätsklinikum Gießen und Marburg	Gießen
Germany	Universitätsklinikum Würzburg	Würzburg
Netherlands	The Erasmus University Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Czechia,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients		1 day
Secondary	Device-base measured LV latency in the LV IEGM channel and Far Field channel		1 day
Secondary	12-lead ECG-measured LV latency in the channel with earliest QRS onset		1 day
Secondary	Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel		1 day
Secondary	12-lead ECG-measured latency intervals		1 day