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Completed

NCT Number: NCT02181686

Iperia/Sentus QP Study

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachyarrhythmia Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landesklinikum, Sankt Pölten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate

    Time frame: 3 months

    The safety of the LV lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the LV lead will be the basis for endpoint calculation of the SADE-free rate.

  2. Iperia ICD family: SADE free rate

    Time frame: 3 months

    The safety of the Iperia ICD family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.

Secondary outcomes

  1. LV pacing threshold

    Time frame: 3 months

    Lv pacing threshold measured in the final programmed pacing vector

Other outcomes

  1. Collection of data of interest: Handling of LV lead during implantation

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Iperia Family / Sentus QP Master Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 4, 2014
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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