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Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sentus QP left ventricular lead
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring CRT-D therapy, quadripolar left ventricular lead

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Flinders Medical Center
  • Lyell McEwing Hospital
  • The Northern Hospital
  • Royal Hobart Hospital
  • Nambour General Hospital
  • AKH Linz
  • Klinikum Wels-Grieskirchen GmbH
  • AKH Wien
  • Gentofte Hospital
  • Odense Universitets Hospital
  • DHZ Berlin
  • Maria Heimsuchung Caritas Klinik Pankow
  • Virchow Klinikum
  • Immanuel Klinikum Herzzentrum Bernau
  • Städtisches Krankenhaus Bielefeld Mitte
  • Augusta-Kranken-Anstalt Bochum
  • Augusta Krankenhaus Düsseldorf
  • Heinrich Heine University Düsseldorf
  • Universitätsklinik Erlangen
  • Elisabeth Krankenhaus Essen
  • UHZ Freiburg
  • SRH Wald-Klinikum Gera gGmbH
  • Westpfalzklinikum
  • Städtisches Klinikum St. Georg
  • UKSH Campus Lübeck
  • Marienhospital Lünen
  • Elbekliniken Stade - Buxtehude
  • SBK Villingen Schwenningen
  • SHG-Kliniken Völklingen
  • Universitätsklinikum Würzburg
  • HBK Zwickau
  • Semmelweis University
  • Barzilai Medical Center
  • Soroka Medical Center
  • Rambam Medical Center
  • Hadassah Medical Center
  • Spedali Civili di Brescia
  • Azienda Ospedaliero Sant'Anna Como
  • Nusch
  • Vusch East Slovak Cardiology Institute
  • Hospital Clinic Provincial de Barcelona
  • Hospital Ramón y Cajal Madrid
  • Kantonspital Luzern
  • University Hospital Zürich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sentus QP left ventricular lead

Arm Description

Subjects consented and implanted with a Sentus QP left ventricular lead.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 10, 2014
Last Updated
March 1, 2021
Sponsor
Biotronik SE & Co. KG
Collaborators
Biotronik, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02290028
Brief Title
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Acronym
QP ExCELs
Official Title
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
BIOTRONIK received FDA approval to transition the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
Collaborators
Biotronik, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT-D therapy, quadripolar left ventricular lead

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sentus QP left ventricular lead
Arm Type
Other
Arm Description
Subjects consented and implanted with a Sentus QP left ventricular lead.
Intervention Type
Device
Intervention Name(s)
Sentus QP left ventricular lead
Other Intervention Name(s)
Sentus OTW QP L, Sentus OTW QP S, Sentus OTW QP S-xx/49, Sentus OTW QP L-xx/49
Intervention Description
Implantation of quadripolar left ventricular lead in patients with CRT-D indication
Primary Outcome Measure Information:
Title
Sentus QP Related Complication-free Rate Through 6 Months
Description
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.
Time Frame
6 months
Title
Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months
Description
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.
Time Frame
3 months
Title
Sentus QP Related Complication-free Rate
Description
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.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model
Description
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.
Time Frame
3 months
Title
Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months
Description
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.
Time Frame
3 months
Title
Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model
Description
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.
Time Frame
3 months
Title
Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model
Description
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.
Time Frame
3 months
Title
Sentus QP Time to Complication
Description
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.
Time Frame
6 months
Title
Sentus QP Related Complication-free Rate Per Lead Model
Description
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.
Time Frame
Up to 4 years
Title
Individual Sentus QP Adverse Event Rates
Description
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.
Time Frame
Up to 4 years
Title
Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Curnis, Prof.
Organizational Affiliation
Spedali Civili - Universita di Brescia, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mattias Roser, Dr.
Organizational Affiliation
Charité CBF Berlin, Germany
Official's Role
Study Chair
Facility Information:
City
Fairhope
State/Province
Alabama
Country
United States
City
Anchorage
State/Province
Alaska
Country
United States
City
Chula Vista
State/Province
California
Country
United States
City
Inglewood
State/Province
California
Country
United States
City
Rancho Mirage
State/Province
California
Country
United States
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Aurora
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Pensacola
State/Province
Florida
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United States
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Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
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Atlanta
State/Province
Georgia
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United States
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Chicago
State/Province
Illinois
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United States
City
Joliet
State/Province
Illinois
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United States
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Fort Wayne
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Indiana
Country
United States
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Iowa City
State/Province
Iowa
Country
United States
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Kansas City
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Bangor
State/Province
Maine
Country
United States
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Boston
State/Province
Massachusetts
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United States
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Burlington
State/Province
Massachusetts
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United States
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Fall River
State/Province
Massachusetts
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United States
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Worcester
State/Province
Massachusetts
Country
United States
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Ann Arbor
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Michigan
Country
United States
City
Detroit
State/Province
Michigan
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United States
City
Ypsilanti
State/Province
Michigan
Country
United States
City
Tupelo
State/Province
Mississippi
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Saint Charles
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Kalispell
State/Province
Montana
Country
United States
City
Browns Mills
State/Province
New Jersey
Country
United States
City
Englewood
State/Province
New Jersey
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Neptune
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Flushing
State/Province
New York
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Valhalla
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Fargo
State/Province
North Dakota
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
City
Bryn Mawr
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Wynnewood
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
The Woodlands
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Cheyenne
State/Province
Wyoming
Country
United States
Facility Name
Flinders Medical Center
City
Bedford Park
Country
Australia
Facility Name
Lyell McEwing Hospital
City
Elizabeth Vale
Country
Australia
Facility Name
The Northern Hospital
City
Epping
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
Country
Australia
Facility Name
Nambour General Hospital
City
Nambour
Country
Australia
Facility Name
AKH Linz
City
Linz
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
Country
Austria
Facility Name
AKH Wien
City
Wien
Country
Austria
Facility Name
Gentofte Hospital
City
Hellerup
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
Country
Denmark
Facility Name
DHZ Berlin
City
Berlin
Country
Germany
Facility Name
Maria Heimsuchung Caritas Klinik Pankow
City
Berlin
Country
Germany
Facility Name
Virchow Klinikum
City
Berlin
Country
Germany
Facility Name
Immanuel Klinikum Herzzentrum Bernau
City
Bernau
Country
Germany
Facility Name
Städtisches Krankenhaus Bielefeld Mitte
City
Bielefeld
Country
Germany
Facility Name
Augusta-Kranken-Anstalt Bochum
City
Bochum
Country
Germany
Facility Name
Augusta Krankenhaus Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Heinrich Heine University Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinik Erlangen
City
Erlangen
Country
Germany
Facility Name
Elisabeth Krankenhaus Essen
City
Essen
Country
Germany
Facility Name
UHZ Freiburg
City
Freiburg
Country
Germany
Facility Name
SRH Wald-Klinikum Gera gGmbH
City
Gera
Country
Germany
Facility Name
Westpfalzklinikum
City
Kaiserslautern
Country
Germany
Facility Name
Städtisches Klinikum St. Georg
City
Leipzig
Country
Germany
Facility Name
UKSH Campus Lübeck
City
Lübeck
Country
Germany
Facility Name
Marienhospital Lünen
City
Lünen
Country
Germany
Facility Name
Elbekliniken Stade - Buxtehude
City
Stade
Country
Germany
Facility Name
SBK Villingen Schwenningen
City
Villingen
Country
Germany
Facility Name
SHG-Kliniken Völklingen
City
Völklingen
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
HBK Zwickau
City
Zwickau
Country
Germany
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Azienda Ospedaliero Sant'Anna Como
City
Como
Country
Italy
Facility Name
Nusch
City
Bratislava
Country
Slovakia
Facility Name
Vusch East Slovak Cardiology Institute
City
Kosice
Country
Slovakia
Facility Name
Hospital Clinic Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Ramón y Cajal Madrid
City
Madrid
Country
Spain
Facility Name
Kantonspital Luzern
City
Luzern
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

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