Iperia/Sentus QP Study

Biotronik

Status: Completed

Conditions: Heart Failure; Tachyarrhythmia

Study type: Observational

Funder types: Industry

Identifiers

NCT02181686

CR015

Details and patient eligibility

About

The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is able to understand the nature of the study and provides written informed consent.
• Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy.
• Patient is able and willing to complete the planned follow-up visits at the investigational site.
• Patient accepts the Home Monitoring® concept.
• Age is ≥ 18 years.
• Sentus QP group only: Patient is a candidate for a new (de novo) implant or an upgrade from an existing ICD or pacemaker utilizing a BIOTRONIK Sentus QP lead

Exclusion criteria

• Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy.
• Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead.
• Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
• Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
• Patient is pregnant or breastfeeding.
• Life expectancy of less than 3 months
• Participating in another cardiac clinical investigation with active treatment arm.

Trial design

152 participants in 2 patient groups

Sentus QP group

Description:

Patients with standard indication for CRT-D therapy who will be implanted with Sentus QP LV lead and the BIOTRONIK HF-T QP device.

VR-T/DR-T group

Description:

Patients with standard indication for ICD therapy who will be implanted with either single chamber ICD or dual chamber ICD of the Iperia ICD family