Heart FailureEffaceQNCT01484613
Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads
An observational study of Heart Failure, run by Abbott Medical Devices at 16 sites in Germany.
Trial summary
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- quadripolar LV lead (Quartet)
- Type of treatment
- Medical device
- How many people
- 337 participants
- Where
- 16 sitesGermany
- Study dates
- Nov 2011to Jun 2014
- 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 who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.
Who may be able to join
- Indication for implantation of a CRT-D
- Age >= 18 years
- Written informed consent
Who cannot join
- Already implanted LV or coronary sinus lead
- Previous unsuccessful LV lead implant attempt
- Patient is eligible for heart transplantation
- Comorbidities that results in life expectancy of less than 12 months
- Known pregnancy
- Inability to provide written patient informed consent
Show all 9Show fewer
- Participation to another study with active treatment arm (i.e. randomized studies etc...)
- Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
- Patient is not able to understand or answer the quality of life questionaire
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Klinikum Coburg GmbH
Coburg, 96450
Evangelisches Krankenhaus Kalk
Cologne, 51103
Krankenhaus Mörsenbroich-Rath GmbH
Düsseldorf, 40472
Klinikum Esslingen
Esslingen am Neckar, 73730
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60389
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, 37073
Medizinische Hochschule Hannover
Hanover, 30625
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
St.-Marien-Hospital GmbH
Lünen, 44534
Klinikum Magdeburg gGmbH
Magdeburg, 39130
Marien-Hospital
Marl, 45768
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, 81377
Universitätsklinikum Münster
Münster, 48149
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, 49074
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, 06484
About this study
Official title: Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.
Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.
Read the detailed description
Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:
- Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
- LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)
- Conditions
- Heart Failure
- Being tested
- quadripolar LV lead (Quartet)
- Keywords
- Hear Failure, Cardiac resynchronization, CRT-D, quadripolar
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadripolar LV lead (Quartet)Device
Also called Quartet
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
| Study group | Role | What they receive |
|---|---|---|
| Quadripolar lead | All participants receive a CRT-D system with quadripolar lead Receives: Device: quadripolar LV lead (Quartet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one acceptable lead vector
Definition of acceptable lead vector:
Any LV vector that complies in both tested body positions with both criteria:
- Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
- LV pacing threshold is less or equals 2.5V@0.5ms
Measured: Pre hospital discharge (PHD) to 3 months
Secondary outcomes (5)
Quality of Life
Minnesota living with heart failure questionaire
Measured: Baseline to 3 months
Phrenic nerve stimulation (PNS)
- Incidence of PNS per LV pacing vector
- Freedom from PNS for the permanently programmed LV vector
Measured: PHD to 3 months
LV pacing thresholds
- LV pacing thresholds per LV vector
- Incidence of elevated (>2.5V/0.5ms) LV pacing thresholds per LV vector
Measured: PHD to 3 months
Number of acceptable LV lead vectors per patient
Measured: PHD to 3 months
Finally programmed LV lead vector
- Need for reprogramming
- Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors
Measured: PHD to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
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.
- 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
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Brachmann, Prof., Principal investigator, Klinikum Coburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484613
- Sponsor's protocol ID
- H56
- Acronym
- EffaceQ
- Status last verified
- Feb 2019
- First submitted
- 30 Nov 2011
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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 Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads
- ClinicalTrials.gov ID
- NCT01484613
- Acronym / sponsor ID
- EffaceQ / H56
- Conditions
- Heart Failure
- Keywords
- Hear Failure, Cardiac resynchronization, CRT-D, quadripolar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Dec 2011 (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.
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.
Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.
Detailed description
Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:
- Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
- LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadripolar lead | – | Device: quadripolar LV lead (Quartet)All participants receive a CRT-D system with quadripolar lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.
Key inclusion criteria (3 listed)
- Indication for implantation of a CRT-D
- Age >= 18 years
- Written informed consent
Key exclusion criteria (9 listed)
- Already implanted LV or coronary sinus lead
- Previous unsuccessful LV lead implant attempt
- Patient is eligible for heart transplantation
- Comorbidities that results in life expectancy of less than 12 months
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quadripolar LV lead (Quartet)Also: QuartetAll participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from | Device | Quadripolar lead |
Primary outcome
Percentage of patients with at least one acceptable lead vector
Time frame: Pre hospital discharge (PHD) to 3 months
Definition of acceptable lead vector: Any LV vector that complies in both tested body positions with both criteria: 1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold 2. LV pacing threshold is less or equals 2.5V@0.5ms
5 secondary outcomes
Quality of Life
Time frame: Baseline to 3 months
Phrenic nerve stimulation (PNS)
Time frame: PHD to 3 months
LV pacing thresholds
Time frame: PHD to 3 months
Number of acceptable LV lead vectors per patient
Time frame: PHD to 3 months
Finally programmed LV lead vector
Time frame: PHD to 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 4 Feb 2019.
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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.
Johannes Brachmann, Prof. principal investigator
Klinikum Coburg GmbH
16 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 16 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 3 inclusion and 9 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 16 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?
Percentage of patients with at least one acceptable lead vector (time frame: Pre hospital discharge (PHD) to 3 months). 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 4 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.