Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
NCT ID: NCT02290028
Last Updated: 2021-03-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
2226 participants
INTERVENTIONAL
2014-12-16
2020-01-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during the ongoing post approval phase (US sites only).
A protocol update was implemented on September 6, 2019 to transition the long-term follow up for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Iperia/Sentus QP Study
NCT02181686
Safety and Performance Study of the Siello S Pacing Lead
NCT01791127
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
NCT03253809
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
NCT00990665
Quadripolar CRT-D On Currently Approved Lead SystemS
NCT02232984
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sentus QP left ventricular lead
Subjects consented and implanted with a Sentus QP left ventricular lead.
Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
* Patient is able to understand the nature of the clinical investigation and provide written informed consent
* Patient is able and willing to complete all routine study visits at the investigational site through 5 years of follow-up
* Patient accepts Home Monitoring® concept
* Age ≥ 18 years
Exclusion Criteria
* Contraindication to CRT-D therapy
* Currently implanted with an endocardial or epicardial left ventricular lead or had prior attempt to place a left ventricular lead
* Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that is planned to occur within 6 months after implant or ablation that is planned to occur within 90 days after implant (ablations planned to occur prior to or at implant are not exclusionary)
* Expected to receive a heart transplant or ventricular assist device within 6 months
* Life expectancy less than 12 months
* Participation in any other investigational cardiac clinical investigation during the course of the study
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Pregnant or breast-feeding at time of enrollment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik, Inc.
INDUSTRY
Biotronik SE & Co. KG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antonio Curnis, Prof.
Role: STUDY_CHAIR
Spedali Civili - Universita di Brescia, Italy
Mattias Roser, Dr.
Role: STUDY_CHAIR
Charité CBF Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fairhope, Alabama, United States
Anchorage, Alaska, United States
Chula Vista, California, United States
Inglewood, California, United States
Rancho Mirage, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Joliet, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Fall River, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Ypsilanti, Michigan, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
Saint Charles, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
Browns Mills, New Jersey, United States
Englewood, New Jersey, United States
Hackensack, New Jersey, United States
Neptune City, New Jersey, United States
Brooklyn, New York, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Valhalla, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Bryn Mawr, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Amarillo, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Milwaukee, Wisconsin, United States
Cheyenne, Wyoming, United States
Flinders Medical Center
Bedford Park, , Australia
Lyell McEwing Hospital
Elizabeth Vale, , Australia
The Northern Hospital
Epping, , Australia
Royal Hobart Hospital
Hobart, , Australia
Nambour General Hospital
Nambour, , Australia
AKH Linz
Linz, , Austria
AKH Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Gentofte Hospital
Hellerup, , Denmark
Odense Universitets Hospital
Odense, , Denmark
DHZ Berlin
Berlin, , Germany
Maria Heimsuchung Caritas Klinik Pankow
Berlin, , Germany
Virchow Klinikum
Berlin, , Germany
Immanuel Klinikum Herzzentrum Bernau
Bernau, , Germany
Städtisches Krankenhaus Bielefeld Mitte
Bielefeld, , Germany
Augusta-Kranken-Anstalt Bochum
Bochum, , Germany
Augusta Krankenhaus Düsseldorf
Düsseldorf, , Germany
Heinrich Heine University Düsseldorf
Düsseldorf, , Germany
Universitätsklinik Erlangen
Erlangen, , Germany
Elisabeth Krankenhaus Essen
Essen, , Germany
UHZ Freiburg
Freiburg im Breisgau, , Germany
SRH Wald-Klinikum Gera gGmbH
Gera, , Germany
Westpfalzklinikum
Kaiserslautern, , Germany
Städtisches Klinikum St. Georg
Leipzig, , Germany
UKSH Campus Lübeck
Lübeck, , Germany
Marienhospital Lünen
Lünen, , Germany
Elbekliniken Stade - Buxtehude
Stade, , Germany
SBK Villingen Schwenningen
Villingen, , Germany
SHG-Kliniken Völklingen
Völklingen, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
HBK Zwickau
Zwickau, , Germany
Semmelweis University
Budapest, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Spedali Civili di Brescia
Brescia, , Italy
Azienda Ospedaliero Sant'Anna Como
Como, , Italy
Nusch
Bratislava, , Slovakia
Vusch East Slovak Cardiology Institute
Košice, , Slovakia
Hospital Clinic Provincial de Barcelona
Barcelona, , Spain
Hospital Ramón y Cajal Madrid
Madrid, , Spain
Kantonspital Luzern
Lucerne, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.