Postoperative Cardiac ComplicationMORE-CRTNCT01510652
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
A study testing BiP Group and Quad Group in people with Postoperative Cardiac Complication and Heart Failure, run by Abbott Medical Devices at 64 sites in 13 countries.
Trial summary
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction
- What is being tested?
- BiP Group and Quad Group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,078 participants
- Where
- 64 sitesin 13 countries
- Study dates
- Nov 2011to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- Patients age is 18 years or greater
- Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
- Patients must be willing and able to comply with all study requirements
Who cannot join
- Patients with a life expectancy <12 months.
- Patients who are or may potentially be pregnant.
- Patient has suffered any of the following in the 4 weeks prior to enrolment:
- Myocardial Infarction (MI)
- Coronary Artery Bypass Graft (CABG)
- Unstable Angina Pectoris
- Patient has primary valvular disease which has not been corrected
Trial locations and contacts
64 sites in 13 countries.
64 sites in 13 countries
France12 sites
CHU La Cavale Blanche
Brest
CHU Gabriel Montpied
Clermont-Ferrand
CHRU Hopital Albert Michallon
Grenoble
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon
Hopital de la Timone
Marseille
Hopital du Nord - CH Bourrely St. Antoine
Marseille
CHU Hopital G&R Laennec
Nantes
Nouvelles Cliniques Nantaises
Nantes
CHRU Hopital de Pontchaillou
Rennes
CHRU Hopital Charles Nicolle
Rouen
CHU St. Etienne
Saint-Priest-en-Jarez
Clinique du Tonkin
Villeurbanne
Germany11 sites
Charite Campus Virchow Klinikum
Berlin
Unfallkrankenhaus Berlin-Marzahn
Berlin
Stadtische Kliniken Bielefeld
Bielefeld
Klinikum Coburg
Coburg
Elisabeth-Krankenhaus
Essen
Universitatsklinikum Greifswald
Greifswald
Universitatskliniken des Saarlandes
Homburg
Universitatsklinikum Leipzig
Leipzig
Klinikum Ludenscheid
Lüdenscheid
Stadtisches Klinikum Ludwigshafen
Ludwigshafen
Krankenhaus der Barmherzigen
Trier
Italy9 sites
Policlinico S. Orsola & Malpighi
Bologna
Azienda Ospedaliera S.Anna e S.Sebastiano
Caserta
Azienda Ospedaliera Mater Domini
Catanzaro
Ospedale Vito Fazzi
Lecce
Ospedale Maggiore della Carità
Novara
Policlinico Casilino
Rome
Ospedale SS. Annunziata
Taranto
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torino
Ospedale Civile Maggiore Verona Borgo Trento
Verona
Canada5 sites
Foothills Medical Center
Calgary
Royal Alexandra Hospital
Edmonton
QE II Health Sciences
Halifax
Institut de Cardiologie du Quebec - Hopital Laval
Québec
HSC Heastern Health
St. Johns
United Kingdom5 sites
Queen Elizabeth Hospital
Birmingham
Royal Bournemouth Hospital
Bournemouth
University Hospital of Wales
Cardiff
St. Thomas Hospital
London
James Cook University Hospital
Middlesbrough
Israel4 sites
Barzilai Medical Center
Ashkelon
Soroka University Hospital
Beersheba
Kaplan Medical Center
Rehovot
Sheba Medical Center
Tel HaShomer
Netherlands4 sites
Amphia Hospital
Breda
Medisch Spectrum Twente
Enschede
Haga Ziekenhuis
The Hague
MC Haaglanden
The Hague
Switzerland4 sites
Basel University Hospital
Basel
Hopital Cantonal Universitaire de Geneva
Geneva
Fondazione Cardiocentro Ticino
Lugano
Universitaets Spital Zuerich
Zurich
Spain3 sites
Hospital de Basurto
Bilbao
Hospital Ramon y Cajal
Madrid
Hospital Universitari La Fe
Valencia
Finland2 sites
Paijat-Hame Central Hospital
Lahti
Tampere University Hospital
Tampere
India2 sites
All India Institute of Medical Sciences
New Delhi
Escorts Heart Institute and Research Center
New Delhi
About this study
Official title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
- Conditions
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation, Perioperative/Postoperative Complications
- Being tested
- BiP Group, Quad Group
- Keywords
- Cardiac Resynchronization therapy,, Heart Failure,, Left Ventricular Lead,, Quadripolar Left ventricular Lead,, Phrenic Nerve Stimulation,, Intra and post operative related complications
- Medical subject headings
- Heart Failure, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiP GroupProcedure or surgery
Implantation of standard Left Ventricular (LV) lead
Quad GroupDevice
Implantation of quadripolar Left ventricular (LV) lead Quartet
| Study group | Role | What they receive |
|---|---|---|
| Quad Group | Active comparator | Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Receives: Device: Quad Group |
| BiP Group | Active comparator | Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Receives: Procedure: BiP Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead Performance
Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.
Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
Measured: 6 months
Secondary outcomes (2)
Percentage of Cardiac Resynchronization Therapy Responders
Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Measured: Baseline and 6 months
Implant Duration
This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.
Measured: Total duration of the implant procedure reported at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cardiac ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Boriani, Pro., Principal investigator, Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510652
- Sponsor's protocol ID
- CR-11-006-HF-ID
- Acronym
- MORE-CRT
- Status last verified
- Jan 2019
- First submitted
- 30 Nov 2011
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.
PubMed 29766873
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
- ClinicalTrials.gov ID
- NCT01510652
- Acronym / sponsor ID
- MORE-CRT / CR-11-006-HF-ID
- Conditions
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation, Perioperative/Postoperative Complications
- Keywords
- Cardiac Resynchronization therapy,, Heart Failure,, Left Ventricular Lead,, Quadripolar Left ventricular Lead,, Phrenic Nerve Stimulation,, Intra and post operative related complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,078 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Posted 23 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quad Group | Active comparator | Device: Quad GroupPatients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet |
| BiP Group | Active comparator | Procedure: BiP GroupPatients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- Patients age is 18 years or greater
- Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
- Patients must be willing and able to comply with all study requirements
Key exclusion criteria (7 listed)
- Patients with a life expectancy <12 months.
- Patients who are or may potentially be pregnant.
- Patient has suffered any of the following in the 4 weeks prior to enrolment:
- Patient has primary valvular disease which has not been corrected
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 |
|---|---|---|
| BiP GroupImplantation of standard Left Ventricular (LV) lead | Procedure or surgery | BiP Group |
| Quad GroupImplantation of quadripolar Left ventricular (LV) lead Quartet | Device | Quad Group |
Primary outcome
Lead Performance
Time frame: 6 months
Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
2 secondary outcomes
Percentage of Cardiac Resynchronization Therapy Responders
Time frame: Baseline and 6 months
Implant Duration
Time frame: Total duration of the implant procedure reported at the end of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29766873Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.
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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.
Giuseppe Boriani, Pro. principal investigator
Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
64 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiP Group and Quad Group in people with Postoperative Cardiac Complication and Heart Failure, run by Abbott Medical Devices at 64 sites in 13 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 4 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 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 64 sites in France, Germany, Italy, Canada, United Kingdom and 8 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?
Yes. Results are posted in the registry (first posted 23 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lead Performance (time frame: 6 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 NCT01510652, 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 15 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.