Heart FailureEffaceNCT01244308
Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
An observational study of Heart Failure, run by Abbott Medical Devices at 10 sites in Germany.
Trial summary
It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 132 participants
- Where
- 10 sitesGermany
- Study dates
- Mar 2008to Aug 2011
- 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: Patients with indication for implantation of CRT-D device
Who may be able to join
- indication for CRT-D implantation / upgrade
- written informed consent
Who cannot join
- pregnancy
- age < 18 years
- patients, who cannot visit the routine follow ups (within first 3.5months)
- participants to other studies with active treatment arm
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Medizinische Einrichtungen der RWTH Aachen
Aachen, 52074
Hufeland Klinikum GmbH
Bad Langensalza, 99947
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60389
Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen
Giessen, 35392
Universitäres Herzzentrum Hamburg GmbH (UHZ)
Hamburg, 20246
Katholisches Krankenhaus Marienhospital Universitätsklinik
Herne, 44625
Klinikum Kassel gGmbH
Kassel, 34125
Universitätsklinikum Leipzig AÖR
Leipzig, 04103
Niels-Stensen-Kliniken Marienhospital
Osnabrück, 49074
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, 06484
About this study
Official title: Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in CRT Patients
It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.
- Conditions
- Heart Failure
- Keywords
- Phrenic nerve stimulation, LV pacing configuration, CRT, Cardiac resynchronisation therapy, Heart failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of patients with at least one acceptable LV pacing configuration.
Amount of patients with at least one acceptable, programmable LV pacing configuration. Definition of acceptable LV pacing configuration: LV pacing threshold <=2.5V@0.5ms AND Phrenic nerve threshold is at least twice as high as LV pacing threshold AND LV pacing impedance >=200 Ohms.
Only patients with implanted CRT-D and bipolar leftventricular lead are taken into account.
Measured: First Follow Up after hospital discharge (approx. 1-3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Klein, Dr. med., Principal investigator, Universitätsklinikum Leipzig AÖR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244308
- Sponsor's protocol ID
- T86
- Acronym
- Efface
- Status last verified
- Feb 2019
- First submitted
- 17 Nov 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Klein N, Klein M, Weglage H, Przibille O, Fischer S, Trappe HJ, Birkenhauer F, Pfeiffer D; Efface Phrenic Stim Study Group. Clinical efficacy of left ventricular pacing vector programmability in cardiac resynchronization therapy defibrillator patients for management of phrenic nerve stimulation and/or elevated left ventricular pacing thresholds: insights from the Efface Phrenic Stim study. Europace. 2012 Jun;14(6):826-32. doi: 10.1093/europace/eur412. Epub 2012 Jan 25.
PubMed 22277645
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in CRT Patients
- ClinicalTrials.gov ID
- NCT01244308
- Acronym / sponsor ID
- Efface / T86
- Conditions
- Heart Failure
- Keywords
- Phrenic nerve stimulation, LV pacing configuration, CRT, Cardiac resynchronisation therapy, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Nov 2010 (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.
It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for implantation of CRT-D device
Key inclusion criteria (2 listed)
- indication for CRT-D implantation / upgrade
- written informed consent
Key exclusion criteria (4 listed)
- pregnancy
- age < 18 years
- patients, who cannot visit the routine follow ups (within first 3.5months)
- participants to other studies with active treatment arm
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
Amount of patients with at least one acceptable LV pacing configuration.
Time frame: First Follow Up after hospital discharge (approx. 1-3 months)
Amount of patients with at least one acceptable, programmable LV pacing configuration. Definition of acceptable LV pacing configuration: LV pacing threshold <=2.5V@0.5ms AND Phrenic nerve threshold is at least twice as high as LV pacing threshold AND LV pacing impedance >=200 Ohms. Only patients with implanted CRT-D and bipolar leftventricular lead are taken into account.
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 4 Feb 2019.
- Results publication: PubMed 22277645Klein N, Klein M, Weglage H, Przibille O, Fischer S, Trappe HJ, Birkenhauer F, Pfeiffer D; Efface Phrenic Stim Study Group. Clinical efficacy of left ventricular pacing vector programmability in cardiac resynchronization therapy defibrillator patients for management of phrenic nerve stimulation and/or elevated left ventricular pacing thresholds: insights from the Efface Phrenic Stim study. Europace. 2012 Jun;14(6):826-32. doi: 10.1093/europace/eur412. Epub 2012 Jan 25.
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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.
Norbert Klein, Dr. med. principal investigator
Universitätsklinikum Leipzig AÖR
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 10 sites in Germany.
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 2 inclusion and 4 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
Amount of patients with at least one acceptable LV pacing configuration. (time frame: First Follow Up after hospital discharge (approx. 1-3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244308, which also lists 1 linked publication.
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 4 Feb 2019.