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

• Sponsor: Biotronik SE & Co. KG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02290028
• Collaborator: Biotronik, Inc. (Industry)
• Enrollment: 2,226
• Locations: 119
• Arm: 1
• Actual Duration (Months): 61.2
• Patients Per Site: 18.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Sentus QP left ventricular lead	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2226 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
• Actual Study Start Date: Dec 16, 2014
• Actual Primary Completion Date: Jan 23, 2020
• Actual Study Completion Date: Jan 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Sentus QP left ventricular lead Subjects consented and implanted with a Sentus QP left ventricular lead.	Device: Sentus QP left ventricular lead; Implantation of quadripolar left ventricular lead in patients with CRT-D indication; Other Names: Sentus OTW QP L Sentus OTW QP S Sentus OTW QP S-xx/49 Sentus OTW QP L-xx/49

Outcome Measures

Primary Outcome Measures

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

2. Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months [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. Sentus QP Related Complication-free Rate [Up to 4 years]

   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

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

   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.

2. Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months [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. Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model [3 months]

   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.

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

   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.

5. Sentus QP Time to Complication [6 months]

   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. Sentus QP Related Complication-free Rate Per Lead Model [Up to 4 years]

   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.

7. Individual Sentus QP Adverse Event Rates [Up to 4 years]

   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.

8. Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fairhope	Alabama	United States
2		Anchorage	Alaska	United States
3		Chula Vista	California	United States
4		Inglewood	California	United States
5		Rancho Mirage	California	United States
6		Aurora	Colorado	United States
7		Washington	District of Columbia	United States
8		Orlando	Florida	United States	32803
9		Orlando	Florida	United States	32806
10		Pensacola	Florida	United States
11		Tampa	Florida	United States	33613
12		Atlanta	Georgia	United States
13		Chicago	Illinois	United States
14		Joliet	Illinois	United States
15		Fort Wayne	Indiana	United States
16		Iowa City	Iowa	United States
17		Kansas City	Kansas	United States
18		Lexington	Kentucky	United States	40503
19		Lexington	Kentucky	United States	40536
20		New Orleans	Louisiana	United States
21		Bangor	Maine	United States
22		Boston	Massachusetts	United States
23		Burlington	Massachusetts	United States
24		Fall River	Massachusetts	United States
25		Worcester	Massachusetts	United States
26		Ann Arbor	Michigan	United States
27		Detroit	Michigan	United States
28		Ypsilanti	Michigan	United States
29		Tupelo	Mississippi	United States
30		Kansas City	Missouri	United States
31		Saint Charles	Missouri	United States
32		Saint Louis	Missouri	United States	63110
33		Saint Louis	Missouri	United States	63136
34		Springfield	Missouri	United States
35		Kalispell	Montana	United States
36		Browns Mills	New Jersey	United States
37		Englewood	New Jersey	United States
38		Hackensack	New Jersey	United States
39		Neptune	New Jersey	United States
40		Bronx	New York	United States
41		Brooklyn	New York	United States
42		Flushing	New York	United States
43		New York	New York	United States	10016
44		New York	New York	United States	10021
45		New York	New York	United States	10025
46		New York	New York	United States	10029
47		Valhalla	New York	United States
48		Asheville	North Carolina	United States
49		Chapel Hill	North Carolina	United States
50		Greensboro	North Carolina	United States
51		Greenville	North Carolina	United States
52		Winston-Salem	North Carolina	United States	27103
53		Winston-Salem	North Carolina	United States	27157
54		Fargo	North Dakota	United States
55		Cincinnati	Ohio	United States	45219
56		Columbus	Ohio	United States	43210
57		Columbus	Ohio	United States	43214
58		Toledo	Ohio	United States	43615
59		Bryn Mawr	Pennsylvania	United States
60		Philadelphia	Pennsylvania	United States
61		Wynnewood	Pennsylvania	United States
62		Warwick	Rhode Island	United States
63		Anderson	South Carolina	United States
64		Columbia	South Carolina	United States
65		Greenville	South Carolina	United States
66		Chattanooga	Tennessee	United States
67		Amarillo	Texas	United States
68		Fort Worth	Texas	United States
69		San Antonio	Texas	United States
70		The Woodlands	Texas	United States
71		Salt Lake City	Utah	United States
72		Burlington	Vermont	United States
73		Norfolk	Virginia	United States
74		Milwaukee	Wisconsin	United States
75		Cheyenne	Wyoming	United States
76	Flinders Medical Center	Bedford Park		Australia
77	Lyell McEwing Hospital	Elizabeth Vale		Australia
78	The Northern Hospital	Epping		Australia
79	Royal Hobart Hospital	Hobart		Australia
80	Nambour General Hospital	Nambour		Australia
81	AKH Linz	Linz		Austria
82	Klinikum Wels-Grieskirchen GmbH	Wels		Austria
83	AKH Wien	Wien		Austria
84	Gentofte Hospital	Hellerup		Denmark
85	Odense Universitets Hospital	Odense		Denmark
86	DHZ Berlin	Berlin		Germany
87	Maria Heimsuchung Caritas Klinik Pankow	Berlin		Germany
88	Virchow Klinikum	Berlin		Germany
89	Immanuel Klinikum Herzzentrum Bernau	Bernau		Germany
90	Städtisches Krankenhaus Bielefeld Mitte	Bielefeld		Germany
91	Augusta-Kranken-Anstalt Bochum	Bochum		Germany
92	Augusta Krankenhaus Düsseldorf	Düsseldorf		Germany
93	Heinrich Heine University Düsseldorf	Düsseldorf		Germany
94	Universitätsklinik Erlangen	Erlangen		Germany
95	Elisabeth Krankenhaus Essen	Essen		Germany
96	UHZ Freiburg	Freiburg		Germany
97	SRH Wald-Klinikum Gera gGmbH	Gera		Germany
98	Westpfalzklinikum	Kaiserslautern		Germany
99	Städtisches Klinikum St. Georg	Leipzig		Germany
100	UKSH Campus Lübeck	Lübeck		Germany
101	Marienhospital Lünen	Lünen		Germany
102	Elbekliniken Stade - Buxtehude	Stade		Germany
103	SBK Villingen Schwenningen	Villingen		Germany
104	SHG-Kliniken Völklingen	Völklingen		Germany
105	Universitätsklinikum Würzburg	Würzburg		Germany
106	HBK Zwickau	Zwickau		Germany
107	Semmelweis University	Budapest		Hungary
108	Barzilai Medical Center	Ashkelon		Israel
109	Soroka Medical Center	Beer Sheva		Israel
110	Rambam Medical Center	Haifa		Israel
111	Hadassah Medical Center	Jerusalem		Israel
112	Spedali Civili di Brescia	Brescia		Italy
113	Azienda Ospedaliero Sant'Anna Como	Como		Italy
114	Nusch	Bratislava		Slovakia
115	Vusch East Slovak Cardiology Institute	Kosice		Slovakia
116	Hospital Clinic Provincial de Barcelona	Barcelona		Spain
117	Hospital Ramón y Cajal Madrid	Madrid		Spain
118	Kantonspital Luzern	Luzern		Switzerland
119	University Hospital Zürich	Zürich		Switzerland

Sponsors and Collaborators

• Biotronik SE & Co. KG
• Biotronik, Inc.

Investigators

• Study Chair: Antonio Curnis, Prof., Spedali Civili - Universita di Brescia, Italy
• Study Chair: Mattias Roser, Dr., Charité CBF Berlin, Germany

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 1, 2017

More Information

Publications

None provided.

• Responsible Party: Biotronik SE & Co. KG
• ClinicalTrials.gov Identifier: NCT02290028
• Other Study ID Numbers: CR016
• First Posted: Nov 13, 2014
• Last Update Posted: Mar 24, 2021
• Last Verified: Jan 1, 2020

• Keywords provided by Biotronik SE & Co. KG: CRT-D therapy; quadripolar left ventricular lead
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D, plus participants that were consented but did not receive a Sentus QP lead or CRT-D.
Period Title: Overall Study
STARTED	2226
COMPLETED	0
NOT COMPLETED	2226

Baseline Characteristics

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Overall Participants	2222
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.8 (10.8)
Sex: Female, Male (Count of Participants)
Female	683 30.7%
Male	1539 69.3%
Race and Ethnicity Not Collected (Count of Participants)
Height (Inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Inches]	68.0 (4.0)
Weight (Pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pounds]	197.3 (50.0)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016.

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	279
Number (95% Confidence Interval) [percentage of participants]	97.1 4.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sentus QP Left Ventricular Lead
	Comments	Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Exact, binomial
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed threshold testing at 3 months post-implant or with available data from remote monitoring or next visits (as pre-specified in the protocol).

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	286
Number (95% Confidence Interval) [percentage of participants]	93.4 4.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sentus QP Left Ventricular Lead
	Comments	Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.002
	Comments
	Method	Exact, binomial
	Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	1727
Number (95% Confidence Interval) [percentage of participants]	98.03 4.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sentus QP Left Ventricular Lead
	Comments	Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed threshold testing at 3 months post-implant.

Arm/Group Title	Sentus QP L Model Left Ventricular Lead	Sentus QP S Model Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.	Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Measure Participants	240	36
Count of Participants [Participants]	226 10.2%	32 NaN

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed novel vector threshold testing at 3 months post-implant.

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	273
Count of Participants [Participants]	261 11.7%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed sensing test at 3 months post-implant.

Arm/Group Title	Sentus QP L Model Left Ventricular Lead	Sentus QP S Model Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.	Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Measure Participants	223	32
Count of Participants [Participants]	223 10%	32 NaN

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and with completed impedance testing at 3 months post-implant.

Arm/Group Title	Sentus QP L Model Left Ventricular Lead	Sentus QP S Model Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.	Participants consented and implanted with a Sentus QP S model left ventricular lead and CRT-D.
Measure Participants	245	36
Count of Participants [Participants]	245 11%	36 NaN

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016.

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	279
Number (95% Confidence Interval) [percentage of participants]	97.1 4.4%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.

Arm/Group Title	Sentus QP L Model Left Ventricular Lead	Sentus QP S Model Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP L model left ventricular lead and CRT-D.	Participants consented and implanted with a Sentus QP S model left ventricular lead CRT-D.
Measure Participants	1306	421
Number (95% Confidence Interval) [percentage of participants]	98.47 4.4%	96.67 NaN

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Post-Market cohort, which included all participants who were enrolled with planned 5 year follow-up and were successfully implanted with a Sentus QP left ventricular lead.

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	1727
Dislodgements	1.39 0.1%
Extracardiac Stimulation	0.17 0%
Mechanical Lead Failure	0.12 0%
Elevated Lead Impedance	0.12 0%
Elevated LV Pacing Threshold	0.06 0%
Electrical Lead Failure	0.06 0%
Cardiac Perforation	0.06 0%

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in the Pre-Market cohort, defined as the study participants who were consented and implanted with a Sentus QP LV lead on or before January 29, 2016, and whom experienced phrenic nerve stimulation or high LV pacing threshold.

Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
Measure Participants	97
Count of Participants [Participants]	73 3.3%

Adverse Events

Time Frame	Though study exit or study termination, an average of 1.2 years, and up to 4 years
Adverse Event Reporting Description	According to the study protocol, sites were required to report all deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
Arm/Group Title	Sentus QP Left Ventricular Lead
Arm/Group Description	Participants consented and implanted with a Sentus QP left ventricular lead and CRT-D.
All Cause Mortality
	Sentus QP Left Ventricular Lead
	Affected / at Risk (%)	# Events
Total	217/2226 (9.7%)
Serious Adverse Events
	Sentus QP Left Ventricular Lead
	Affected / at Risk (%)	# Events
Total	290/2226 (13%)
Cardiac disorders
Cardiac perforation associated with the RA lead	1/2226 (0%)	1
Cardiac perforation associated with the RV lead	3/2226 (0.1%)	3
Cardiac perforation associated with the LV lead	1/2226 (0%)	1
Inability to place LV lead	4/2226 (0.2%)	4
RA lead related lead dislodgement	31/2226 (1.4%)	31
RV lead related lead dislodgement	22/2226 (1%)	23
RV lead related elevated pacing threshold	3/2226 (0.1%)	3
RV lead impedance out of range, high impedance	3/2226 (0.1%)	3
RV lead related clinical failure	3/2226 (0.1%)	3
RV lead related mechanical failure	2/2226 (0.1%)	2
RV lead undersensing or loss of sensing	1/2226 (0%)	1
Endocarditis associated with the RV lead	1/2226 (0%)	1
LV lead related lead dislodgement	59/2226 (2.7%)	66
LV lead related extracardiac stimulation	11/2226 (0.5%)	11
LV lead related mechanical failure	3/2226 (0.1%)	3
LV lead related high pacing threshold	2/2226 (0.1%)	2
LV lead related elevated pacing threshold	2/2226 (0.1%)	2
LV lead related clinical failure	1/2226 (0%)	1
LV lead related loss of capture	1/2226 (0%)	1
ICD device migration	4/2226 (0.2%)	4
ICD device related inappropriate shock or ATP	8/2226 (0.4%)	8
ICD device related electronic failure	1/2226 (0%)	1
RA lead elevated pacing threshold	1/2226 (0%)	1
LV lead electrical lead failure	1/2226 (0%)	1
LV lead impedance out of range, high	1/2226 (0%)	1
General disorders
Twiddler's syndrome	6/2226 (0.3%)	6
Infections and infestations
Implant procedure related infection	23/2226 (1%)	24
Secondary infection	10/2226 (0.4%)	10
Pocket infection	6/2226 (0.3%)	6
Surgical and medical procedures
Cardiac perforation	3/2226 (0.1%)	4
Arrhythmia associated with implant procedure	7/2226 (0.3%)	7
Hematoma	17/2226 (0.8%)	17
Loose set-screw	1/2226 (0%)	1
Pneumothorax	16/2226 (0.7%)	16
Pericarditis	1/2226 (0%)	1
Pleural effusion	4/2226 (0.2%)	4
Pericardial effusion	2/2226 (0.1%)	2
Respiratory arrest	1/2226 (0%)	1
Stroke	1/2226 (0%)	1
Cardiogenic shock	1/2226 (0%)	1
Respiratory distress	3/2226 (0.1%)	3
Renal failure	1/2226 (0%)	1
Wound healing disturbance	3/2226 (0.1%)	3
Venous occlusion	3/2226 (0.1%)	3
Discomfort/pain	1/2226 (0%)	1
Post surgical bleeding	5/2226 (0.2%)	5
Post procedure anemia	2/2226 (0.1%)	2
Allergy to contrast agent	1/2226 (0%)	1
Elevated WBD and labs post procedure	1/2226 (0%)	1
Inflammation and swelling at surgical site	1/2226 (0%)	1
Other (Not Including Serious) Adverse Events
	Sentus QP Left Ventricular Lead
	Affected / at Risk (%)	# Events
Total	711/2226 (31.9%)
Cardiac disorders
Inability to place LV lead	101/2226 (4.5%)	101
RA lead related lead dislodgement	7/2226 (0.3%)	7
RA lead related undersensing	3/2226 (0.1%)	3
RV lead related clinical failure	2/2226 (0.1%)	2
RV lead related extracardiac stimulation	1/2226 (0%)	1
RV lead related high pacing threshold	1/2226 (0%)	1
RV lead related oversensing	1/2226 (0%)	1
LV lead related extracardiac stimulation	258/2226 (11.6%)	316
LV lead related elevated pacing threshold	132/2226 (5.9%)	147
LV lead related lead dislodgement	27/2226 (1.2%)	29
LV lead related loss of capture	24/2226 (1.1%)	26
LV lead impedance out of range, high impedance	19/2226 (0.9%)	20
LV lead related high pacing threshold	38/2226 (1.7%)	40
LV lead related clinical failure	7/2226 (0.3%)	7
LV lead related oversensing	4/2226 (0.2%)	4
LV lead related mechanical failure	2/2226 (0.1%)	2
LV lead related electrical failure	1/2226 (0%)	1
LV lead related loss of sensing	1/2226 (0%)	1
ICD device migration	1/2226 (0%)	1
ICD device related inappropriate shock or ATP	6/2226 (0.3%)	6
ICD device related housing defect	1/2226 (0%)	1
ICD device related high defibrillator (DFT) testing	3/2226 (0.1%)	3
ICD device related pacemaker mediated tachycardia (PMT)	2/2226 (0.1%)	2
RA lead elevated pacing threshold	3/2226 (0.1%)	4
RA lead related extracardiac stimulation	2/2226 (0.1%)	3
RA lead related thrombosis	1/2226 (0%)	1
General disorders
Twiddler's syndrome	3/2226 (0.1%)	3
Rachet syndrome	1/2226 (0%)	1
Infections and infestations
Implant procedure related infection	8/2226 (0.4%)	8
Surgical and medical procedures
Arrhythmia associated with implant procedure	5/2226 (0.2%)	5
Hematoma	12/2226 (0.5%)	13
Coronary sinus dissection	9/2226 (0.4%)	10
Loose set-screw	1/2226 (0%)	1
Pneumothorax	3/2226 (0.1%)	3
Pericardial effusion	4/2226 (0.2%)	4
Pleural effusion	4/2226 (0.2%)	4
Bleeding at surgical site	7/2226 (0.3%)	7
Allergy to surgery prep	6/2226 (0.3%)	6
Unsuccessful defibrillator threshold (DFT) testing	1/2226 (0%)	1
Wound healing disturbance	5/2226 (0.2%)	5
Venous occlusion	6/2226 (0.3%)	6
Discomfort/pain at surgical site	14/2226 (0.6%)	14
Pain in shoulder after system revision	1/2226 (0%)	1
Hypotension after insertion procedure	2/2226 (0.1%)	2
Bleeding caused by surgical prep	1/2226 (0%)	1
Fever after insertion procedure	1/2226 (0%)	1
Emesis after insertion procedure	1/2226 (0%)	1

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.