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Heart FailureQP ExCELsNCT02290028

Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

A study testing Sentus QP left ventricular lead in people with Heart Failure, run by Biotronik SE & Co. KG at 119 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Sentus QP left ventricular lead
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,226 participants
Where
119 sitesin 11 countries
Study dates
16 Dec 2014to 23 Jan 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

119 sites in 11 countries.

119 sites in 11 countries

United States75 sites

  • Study site

    Amarillo, Texas

  • Study site

    Anchorage, Alaska

  • Study site

    Anderson, South Carolina

  • Study site

    Ann Arbor, Michigan

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Bangor, Maine

  • Study site

    Boston, Massachusetts

  • Study site

    Brooklyn, New York

  • Study site

    Browns Mills, New Jersey

  • Study site

    Bryn Mawr, Pennsylvania

  • Study site

    Burlington, Massachusetts

  • Study site

    Burlington, Vermont

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cheyenne, Wyoming

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Columbus, Ohio, 43214

  • Study site

    Detroit, Michigan

  • Study site

    Englewood, New Jersey

  • Study site

    Fairhope, Alabama

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Flushing, New York

  • Study site

    Fort Wayne, Indiana

  • Study site

    Fort Worth, Texas

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Inglewood, California

  • Study site

    Iowa City, Iowa

  • Study site

    Joliet, Illinois

  • Study site

    Kalispell, Montana

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Neptune City, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10025

  • Study site

    New York, New York, 10029

  • Study site

    Norfolk, Virginia

  • Study site

    Orlando, Florida, 32803

  • Study site

    Orlando, Florida, 32806

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Rancho Mirage, California

  • Study site

    Saint Charles, Missouri

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63136

  • Study site

    Tampa, Florida, 33613

  • Study site

    The Bronx, New York

  • Study site

    The Woodlands, Texas

  • Study site

    Toledo, Ohio, 43615

  • Study site

    Tupelo, Mississippi

  • Study site

    Valhalla, New York

  • Study site

    Warwick, Rhode Island

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Worcester, Massachusetts

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Germany21 sites

  • DHZ Berlin

    Berlin

  • Maria Heimsuchung Caritas Klinik Pankow

    Berlin

  • Virchow Klinikum

    Berlin

  • Immanuel Klinikum Herzzentrum Bernau

    Bernau

  • Städtisches Krankenhaus Bielefeld Mitte

    Bielefeld

  • Augusta-Kranken-Anstalt Bochum

    Bochum

  • Augusta Krankenhaus Düsseldorf

    Düsseldorf

  • Heinrich Heine University Düsseldorf

    Düsseldorf

  • Universitätsklinik Erlangen

    Erlangen

  • Elisabeth Krankenhaus Essen

    Essen

  • UHZ Freiburg

    Freiburg im Breisgau

  • SRH Wald-Klinikum Gera gGmbH

    Gera

  • Westpfalzklinikum

    Kaiserslautern

  • Städtisches Klinikum St. Georg

    Leipzig

  • UKSH Campus Lübeck

    Lübeck

  • Marienhospital Lünen

    Lünen

  • Elbekliniken Stade - Buxtehude

    Stade

  • SBK Villingen Schwenningen

    Villingen

  • SHG-Kliniken Völklingen

    Völklingen

  • Universitätsklinikum Würzburg

    Würzburg

  • HBK Zwickau

    Zwickau

Other trials in Germany

Australia5 sites

  • Flinders Medical Center

    Bedford Park

  • Lyell McEwing Hospital

    Elizabeth Vale

  • The Northern Hospital

    Epping

  • Royal Hobart Hospital

    Hobart

  • Nambour General Hospital

    Nambour

Other trials in Australia

Israel4 sites

  • Barzilai Medical Center

    Ashkelon

  • Soroka Medical Center

    Beersheba

  • Rambam Medical Center

    Haifa

  • Hadassah Medical Center

    Jerusalem

Other trials in Israel

Austria3 sites

  • AKH Linz

    Linz

  • AKH Wien

    Vienna

  • Klinikum Wels-Grieskirchen GmbH

    Wels

Other trials in Austria

Denmark2 sites

  • Gentofte Hospital

    Hellerup

  • Odense Universitets Hospital

    Odense

Other trials in Denmark

Italy2 sites

  • Spedali Civili di Brescia

    Brescia

  • Azienda Ospedaliero Sant'Anna Como

    Como

Other trials in Italy

Slovakia2 sites

  • Nusch

    Bratislava

  • Vusch East Slovak Cardiology Institute

    Košice

Other trials in Slovakia

Spain2 sites

  • Hospital Clinic Provincial de Barcelona

    Barcelona

  • Hospital Ramón y Cajal Madrid

    Madrid

Other trials in Spain

Switzerland2 sites

  • Kantonspital Luzern

    Lucerne

  • University Hospital Zürich

    Zurich

Other trials in Switzerland

Hungary1 site

  • Semmelweis University

    Budapest

Other trials in Hungary

About this study

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.

Conditions
Heart Failure
Being tested
Sentus QP left ventricular lead
Keywords
CRT-D therapy, quadripolar left ventricular lead
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentus QP left ventricular leadDevice

    Also called Sentus OTW QP L, Sentus OTW QP S, Sentus OTW QP S-xx/49, Sentus OTW QP L-xx/49

    Implantation of quadripolar left ventricular lead in patients with CRT-D indication

Study groups in NCT02290028
Study groupRoleWhat they receive
Sentus QP left ventricular leadOtherSubjects consented and implanted with a Sentus QP left ventricular lead.
Receives: Device: Sentus QP left ventricular lead

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sentus QP Related Complication-free Rate Through 6 Months

    The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.

    Measured: 6 months

  2. Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months

    The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.

    Measured: 3 months

  3. Sentus QP Related Complication-free Rate

    The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.

    Measured: Up to 4 years

Secondary outcomes (8)

  1. Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model

    The purpose of the secondary endpoint is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implantation in the two different lead types, Sentus OTW QP L and Sentus OTW QP S. This was evaluated as the number of participants with an acceptable pacing threshold out of the total number of patients for each lead model. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector is considered acceptable.

    Measured: 3 months

  2. Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months

    The purpose of this secondary endpoint is to evaluate the number of participants with at least one acceptable LV lead pacing threshold in a novel pacing vector at 3 months post-implantation. This was evaluated as the number of participants with at least one acceptable LV pacing threshold in a novel pacing vector out of the total number of participants with completed novel pacing threshold testing. LV threshold values of less than or equal to 2.5 V at 0.4 ms in a novel pacing vector is considered acceptable.

    Measured: 3 months

  3. Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model

    The purpose of this secondary endpoint is to evaluate acceptable LV lead sensing amplitude at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV sensing amplitude out of the total number of participants. R-wave sensed mean amplitude of greater than or equal to 2 mV is considered acceptable.

    Measured: 3 months

  4. Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model

    The purpose of this secondary endpoint is to evaluate the acceptable LV lead pacing impedance at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV pacing impedance out of the total participants. LV impedance values of greater than 200 Ohms and less than 2000 Ohms is considered acceptable.

    Measured: 3 months

  5. Sentus QP Time to Complication

    The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.

    Measured: 6 months

  6. Sentus QP Related Complication-free Rate Per Lead Model

    The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as percentage of participants without a complication per lead model.

    Measured: Up to 4 years

  7. Individual Sentus QP Adverse Event Rates

    The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.

    Measured: Up to 4 years

  8. Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold

    The purpose of this secondary endpoint is to evaluate the number of participants in whom phrenic nerve stimulation or high LV pacing threshold was be successfully resolved by reprogramming of the LV pacing vector. This is evaluated as the number of participants with successful reprogramming out of all participants experiencing phrenic nerve stimulation or high LV pacing threshold. LV pacing threshold resulting in invasive intervention, or, in the absence of intervention, a lead threshold that has increased two fold from the chronic threshold value, and is unable to achieve a 2:1 safety margin at follow-up is considered a high LV pacing threshold.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study start16 Dec 2014
  3. Primary completion23 Jan 2020
  4. Study completion23 Jan 2020

Why it stopped: BIOTRONIK received FDA approval to transition the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290028
Sponsor's protocol ID
CR016
Acronym
QP ExCELs
Status last verified
Jan 2020
First submitted
10 Nov 2014
Last updated
24 Mar 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Sentus QP left ventricular lead in people with Heart Failure, run by Biotronik SE & Co. KG at 119 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Germany, Australia, Israel, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sentus QP Related Complication-free Rate Through 6 Months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290028.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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