Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

Heart Failure Clinical Trial

— QP ExCELs  

Official title:

Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02290028
• Other study ID #: CR016
• Status: Terminated
• Phase: N/A
• Start date: December 16, 2014
• Est. completion date: January 23, 2020

Study information

• Verified date: January 2020
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2226
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication

Locations

Country	Name	City	State
Australia	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
Austria	AKH Linz	Linz
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	AKH Wien	Wien
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense Universitets Hospital	Odense
Germany	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
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
Hungary	Semmelweis University	Budapest
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka Medical Center	Beer Sheva
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Italy	Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliero Sant'Anna Como	Como
Slovakia	Nusch	Bratislava
Slovakia	Vusch East Slovak Cardiology Institute	Kosice
Spain	Hospital Clinic Provincial de Barcelona	Barcelona
Spain	Hospital Ramón y Cajal Madrid	Madrid
Switzerland	Kantonspital Luzern	Luzern
Switzerland	University Hospital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG	Biotronik, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Denmark,  Germany,  Hungary,  Israel,  Italy,  Slovakia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	3 months
Primary	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.	Up to 4 years
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	Up to 4 years
Secondary	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.	Up to 4 years
Secondary	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.	12 months