Heart FailureNCT02547207
MultiPoint Pacing Mapping Study
An observational study of Heart Failure, run by Abbott Medical Devices at 4 sites in 3 countries.
Trial summary
The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 7 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Dec 2015to Oct 2018
- 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: Heart failure patients meeting specific eligibility criteria
Who may be able to join
- Be scheduled to undergo or have received within the past 30 days an implant of a SJM (St. Jude Medical) MPP CRT-D system with approved standard indication by ESC (European Society of Cardiology) / EHRA (European Heart Rhythm Association) Guidelines
- Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule
- Be in sinus rhythm
Who cannot join
- Complete AV (atrioventricular) block
- Permanent atrial fibrillation
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
- Have had a recent CVA (cerebrovascular accident) or TIA (transient ischemic attack) within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
Show all 13Show fewer
- Be less than 18 years of age
- Be pregnant or plan to become pregnant over the next 7 months
- Have significant peripheral vascular disease
- Have LV thrombus
- Significant aortic valve disease or replacement
- Mitral valvular disease
- Contraindicated for Gadolinium contrast agent
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, D-61231
Herzzentrum Dresden Universitätsklinik
Dresden
About this study
The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings
Measured: up to 30 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: Slow recruitment
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Leclercq, MD, PhD, Principal investigator, University Hospital Rennes, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547207
- Sponsor's protocol ID
- CR-13-004-EU-HF
- Status last verified
- Jan 2019
- First submitted
- 7 May 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultiPoint Pacing Mapping Study
- ClinicalTrials.gov ID
- NCT02547207
- Acronym / sponsor ID
- CR-13-004-EU-HF
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Sep 2015 (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 purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients meeting specific eligibility criteria
Key inclusion criteria (3 listed)
- Be scheduled to undergo or have received within the past 30 days an implant of a SJM (St. Jude Medical) MPP CRT-D system with approved standard indication by ESC (European Society of Cardiology) / EHRA (European Heart Rhythm Association) Guidelines
- Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule
- Be in sinus rhythm
Key exclusion criteria (13 listed)
- Complete AV (atrioventricular) block
- Permanent atrial fibrillation
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
- Have had a recent CVA (cerebrovascular accident) or TIA (transient ischemic attack) within 3 months prior to enrollment
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
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings
Time frame: up to 30 days post-implant
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Christophe Leclercq, MD, PhD principal investigator
University Hospital Rennes, Rennes, France
4 sites in 3 countries: 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 4 sites in 3 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 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 4 sites in Germany, France, United Kingdom. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings (time frame: up to 30 days post-implant). 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 1 Feb 2019.