Clinical trial NCT02290028: Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Official title: Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: CRT-D therapy
quadripolar left ventricular lead
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Biotronik, Inc.
First posted: 2014-11-13
Enrollment: 2226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.

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.


Eligibility criteria: Inclusion Criteria:

* Standard CRT-D indication according to clinical routine
* 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:

* Chronic atrial fibrillation
* 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

Primary outcomes:
measure: Sentus QP Related Complication-free Rate Through 6 Months
timeFrame: 6 months
measure: Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months
timeFrame: 3 months
measure: Sentus QP Related Complication-free Rate
timeFrame: Up to 4 years
Secondary outcomes:
measure: Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model
timeFrame: 3 months
measure: Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months
timeFrame: 3 months
measure: Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model
timeFrame: 3 months
measure: Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model
timeFrame: 3 months
measure: Sentus QP Time to Complication
timeFrame: 6 months
measure: Sentus QP Related Complication-free Rate Per Lead Model
timeFrame: Up to 4 years
measure: Individual Sentus QP Adverse Event Rates
timeFrame: Up to 4 years
measure: Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold
timeFrame: 12 months
Other outcomes:
Locations:
city: Fairhope
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Chula Vista
country: United States
state: California
city: Inglewood
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Fall River
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Saint Charles
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Kalispell
country: United States
state: Montana
city: Browns Mills
country: United States
state: New Jersey
city: Englewood
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Bryn Mawr
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Cheyenne
country: United States
state: Wyoming
city: Bedford Park
country: Australia
facility: Flinders Medical Center
city: Elizabeth Vale
country: Australia
facility: Lyell McEwing Hospital
city: Epping
country: Australia
facility: The Northern Hospital
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Nambour
country: Australia
facility: Nambour General Hospital
city: Linz
country: Austria
facility: AKH Linz
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wien
country: Austria
facility: AKH Wien
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Berlin
country: Germany
facility: DHZ Berlin
city: Berlin
country: Germany
facility: Maria Heimsuchung Caritas Klinik Pankow
city: Berlin
country: Germany
facility: Virchow Klinikum
city: Bernau
country: Germany
facility: Immanuel Klinikum Herzzentrum Bernau
city: Bielefeld
country: Germany
facility: Städtisches Krankenhaus Bielefeld Mitte
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt Bochum
city: Düsseldorf
country: Germany
facility: Augusta Krankenhaus Düsseldorf
city: Düsseldorf
country: Germany
facility: Heinrich Heine University Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Freiburg
country: Germany
facility: UHZ Freiburg
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
city: Kaiserslautern
country: Germany
facility: Westpfalzklinikum
city: Leipzig
country: Germany
facility: Städtisches Klinikum St. Georg
city: Lübeck
country: Germany
facility: UKSH Campus Lübeck
city: Lünen
country: Germany
facility: Marienhospital Lünen
city: Stade
country: Germany
facility: Elbekliniken Stade - Buxtehude
city: Villingen
country: Germany
facility: SBK Villingen Schwenningen
city: Völklingen
country: Germany
facility: SHG-Kliniken Völklingen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zwickau
country: Germany
facility: HBK Zwickau
city: Budapest
country: Hungary
facility: Semmelweis University
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Como
country: Italy
facility: Azienda Ospedaliero Sant'Anna Como
city: Bratislava
country: Slovakia
facility: Nusch
city: Kosice
country: Slovakia
facility: Vusch East Slovak Cardiology Institute
city: Barcelona
country: Spain
facility: Hospital Clinic Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal Madrid
city: Luzern
country: Switzerland
facility: Kantonspital Luzern
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Spedali Civili - Universita di Brescia, Italy
name: Antonio Curnis, Prof.
role: STUDY_CHAIR
affiliation: Charité CBF Berlin, Germany
name: Mattias Roser, Dr.
role: STUDY_CHAIR
References: