Iperia/Sentus QP Study

NCT02181686 | Completed

• 1 other identifier: CR015
• Study Type: observational
• Target: 152
• Locations: 11 countries
• Sites: 24

Brief Summary

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.

Conditions

Heart Failure; Tachyarrhythmia

Keywords

Heart Failure; Iperia ICD family; Sentus QP left ventricular lead; Quadripolar CRT-D system

Outcome Measures

Primary Outcomes (2)

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

  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.

  3 months

• Iperia ICD family: SADE free rate

  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.

  3 months

Secondary Outcomes (1)

• LV pacing threshold

  3 months

Other Outcomes (1)

• Collection of data of interest: Handling of LV lead during implantation

  3 months

Study Arms (2)

Sentus QP group

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient collective consists mainly of heart failure patients with CRT-D indication according to current guidelines. In addition 50 patients with an indication for single or dual chamber ICD will be enrolled in the study. The investigator will select patients who are appropriate for particiation from his general patient population.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (24)

Landesklinikum

Sankt Pölten, Austria

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Aarhus University Hospital

Skejby, Denmark

Location

Jyväskylä Central Hospital

Jyväskylä, Finland

Location

Herz- und Diabetes Zentrum

Bad Oeynhausen, Germany

Location

SRH Wald-Klinikum

Gera, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

UKSH Campus Lübeck

Lübeck, Germany

Location

Märkische Kliniken Lüdenscheid

Lüdenscheid, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

Location

Klinikum München-Bogenhausen

Munich, Germany

Location

Johanniter Krankenhaus

Stendal, Germany

Location

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, 78048, Germany

Location

Ospedale Pugliese Ciaccio

Catanzaro, Italy

Location

Paul Stradins Clinical University Hospital

Riga, Latvia

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

National Heart Centre

Singapore, Singapore

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Kantonsspital Lucerne

Lucerne, Switzerland

Location

Cardiocentro Ticino

Lugano, Switzerland

Location

Triemlispital Zurich

Zurich, Switzerland

Location

Russels Hall Hospital

Brighton, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Tachycardia

Condition Hierarchy (Ancestors)

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

Study Officials

• Werner Jung, Prof. Dr.

  Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

SG (1); DK (3); ES (1); LA (1); NL (2); DE (9); IT (1); CH (3); GB (1); FI (1); AU (1)