Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)
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| ClinicalTrials.gov Identifier: NCT02290028 |
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Recruitment Status :
Terminated
(BIOTRONIK received FDA approval to transition the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.)
First Posted : November 13, 2014
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
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Sponsor:
Biotronik SE & Co. KG
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
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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 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | December 16, 2014 |
| Actual Primary Completion Date : | January 23, 2020 |
| Actual Study Completion Date : | January 23, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Sentus QP left ventricular lead
Subjects consented and implanted with a Sentus QP left ventricular lead.
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Device: Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication
Other Names:
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Primary Outcome Measures :
- Sentus QP Related Complication-free Rate Through 6 Months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 :
- Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model [ Time Frame: 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.
- Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months [ Time Frame: 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 [ Time Frame: 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.
- Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model [ Time Frame: 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.
- Sentus QP Time to Complication [ Time Frame: 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.
- Sentus QP Related Complication-free Rate Per Lead Model [ Time Frame: 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.
- Individual Sentus QP Adverse Event Rates [ Time Frame: 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.
- Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290028
Locations
Show 119 study locations
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)
Documents provided by Biotronik SE & Co. KG:
Documents provided by Biotronik SE & Co. KG:
Study Protocol and Statistical Analysis Plan [PDF] February 1, 2017
| Responsible Party: | Biotronik SE & Co. KG |
| ClinicalTrials.gov Identifier: | NCT02290028 |
| Other Study ID Numbers: |
CR016 |
| First Posted: | November 13, 2014 Key Record Dates |
| Results First Posted: | March 24, 2021 |
| Last Update Posted: | March 24, 2021 |
| Last Verified: | January 2020 |
Keywords provided by Biotronik SE & Co. KG:
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CRT-D therapy quadripolar left ventricular lead |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |