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

Biotronik

Status: Terminated

Conditions: Heart Failure

Treatments: Device: BIOTRONIK CRT-D

Study type: Interventional

Funder types: Industry

Identifiers

NCT03314675

CR022

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

CRT-D Measurements

Other group

Description:

Pre-specified measurements and additional follow-ups

Treatment:

Device: BIOTRONIK CRT-D