Heart FailureNCT02181686
Iperia/Sentus QP Study
An observational study of Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 24 sites in 11 countries.
Trial summary
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Tachyarrhythmia
- How many people
- 152 participants
- Where
- 24 sitesin 11 countries
- Study dates
- Jul 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The patient collective consists mainly of heart failure patients with CRT-D indication according to current guidelines. In addition 50 patients with an indication for single or dual chamber ICD will be enrolled in the study. The investigator will select patients who are appropriate for particiation from his general patient population.
Who may be able to join
- Patient is able to understand the nature of the study and provides written informed consent.
- Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy.
- Patient is able and willing to complete the planned follow-up visits at the investigational site.
- Patient accepts the Home Monitoring® concept.
- Age is ≥ 18 years.
- Sentus QP group only: Patient is a candidate for a new (de novo) implant or an upgrade from an existing ICD or pacemaker utilizing a BIOTRONIK Sentus QP lead
Who cannot join
- Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy.
- Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead.
- Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
- Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
- Patient is pregnant or breastfeeding.
- Life expectancy of less than 3 months
- Participating in another cardiac clinical investigation with active treatment arm.
Trial locations and contacts
24 sites in 11 countries.
24 sites in 11 countries
Germany9 sites
Herz- und Diabetes Zentrum
Bad Oeynhausen
SRH Wald-Klinikum
Gera
Medizinische Hochschule Hannover
Hanover
UKSH Campus Lübeck
Lübeck
Märkische Kliniken Lüdenscheid
Lüdenscheid
Kliniken Maria Hilf GmbH
Mönchengladbach
Klinikum München-Bogenhausen
Munich
Johanniter Krankenhaus
Stendal
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, 78048
Denmark3 sites
Aalborg University Hospital
Aalborg
Odense University Hospital
Odense
Aarhus University Hospital
Skejby
Switzerland3 sites
Kantonsspital Lucerne
Lucerne
Cardiocentro Ticino
Lugano
Triemlispital Zurich
Zurich
Netherlands2 sites
University Medical Center Groningen
Groningen
Isala Klinieken
Zwolle
About this study
Official title: Iperia Family / Sentus QP Master Study
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
- Conditions
- Heart Failure, Tachyarrhythmia
- Keywords
- Heart Failure, Iperia ICD family, Sentus QP left ventricular lead, Quadripolar CRT-D system
- Medical subject headings
- Heart Failure, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sentus QP group | Patients with standard indication for CRT-D therapy who will be implanted with Sentus QP LV lead and the BIOTRONIK HF-T QP device. | |
| VR-T/DR-T group | Patients with standard indication for ICD therapy who will be implanted with either single chamber ICD or dual chamber ICD of the Iperia ICD family |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate
The safety of the LV lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the LV lead will be the basis for endpoint calculation of the SADE-free rate.
Measured: 3 months
Iperia ICD family: SADE free rate
The safety of the Iperia ICD family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
Measured: 3 months
Secondary outcomes (1)
LV pacing threshold
Lv pacing threshold measured in the final programmed pacing vector
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Jung, Prof. Dr., Principal investigator, Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181686
- Sponsor's protocol ID
- CR015
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2014
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iperia Family / Sentus QP Master Study
- ClinicalTrials.gov ID
- NCT02181686
- Acronym / sponsor ID
- CR015
- Conditions
- Heart Failure, Tachyarrhythmia
- Keywords
- Heart Failure, Iperia ICD family, Sentus QP left ventricular lead, Quadripolar CRT-D system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentus QP group | – | –Patients with standard indication for CRT-D therapy who will be implanted with Sentus QP LV lead and the BIOTRONIK HF-T QP device. |
| VR-T/DR-T group | – | –Patients with standard indication for ICD therapy who will be implanted with either single chamber ICD or dual chamber ICD of the Iperia ICD family |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient collective consists mainly of heart failure patients with CRT-D indication according to current guidelines. In addition 50 patients with an indication for single or dual chamber ICD will be enrolled in the study. The investigator will select patients who are appropriate for particiation from his general patient population.
Key inclusion criteria (6 listed)
- Patient is able to understand the nature of the study and provides written informed consent.
- Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy.
- Patient is able and willing to complete the planned follow-up visits at the investigational site.
- Patient accepts the Home Monitoring® concept.
- Age is ≥ 18 years.
Key exclusion criteria (7 listed)
- Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy.
- Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead.
- Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
- Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
- Patient is pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate
Time frame: 3 months
The safety of the LV lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the LV lead will be the basis for endpoint calculation of the SADE-free rate.
Iperia ICD family: SADE free rate
Time frame: 3 months
The safety of the Iperia ICD family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
1 secondary outcome
LV pacing threshold
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Jung, Prof. Dr. principal investigator
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Germany
24 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 24 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 7 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: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Denmark, Switzerland, Netherlands, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 LV lead: Serious Adverse Device Effect (SADE) free rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2015.