Heart FailureNCT02782598
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
An observational study of Heart Failure, run by Abbott Medical Devices at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients. 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?
- CRT+NAVH
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to May 2020
- 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: Enrollment will include patients scheduled to be implanted with MultiPoint Pacing-enabled SJM Quadripolar Pacing Systems
Who may be able to join
- Scheduled for implantation of an MPP-enabled SJM Quadripolar CRT Pacing System
- QRS duration > 140 ms
- Left bundle branch block documented
- Ability to provide informed consent for study participation
- Willing to comply with the study evaluation requirements
- At least 18 years of age
Who cannot join
- Resting ventricular rate >100 bpm
- Intrinsic PR interval > 300 ms
- Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
- A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
- Women who are pregnant or who plan to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.
- Conditions
- Heart Failure
- Being tested
- CRT+NAVH
- Keywords
- Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT+NAVHDevice
Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
| Study group | Role | What they receive |
|---|---|---|
| CRT+NAVH | Surface ECG and pressure-volume loop recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings at the device implant procedure Receives: Device: CRT+NAVH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy (CRT) with Negative Atrioventricular Hysteresis (NAVH) over a range of programmable values
Measured: 1 day
Secondary outcomes (2)
Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction
Acute changes in left ventricular pressure-volume hemodynamics resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
Measured: 1 day
Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction
Changes in surface ECG QRS duration after one day of Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2020
- Study completionMay 2020
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782598
- Sponsor's protocol ID
- CRD_856
- Status last verified
- Jan 2024
- First submitted
- 19 May 2016
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
- ClinicalTrials.gov ID
- NCT02782598
- Acronym / sponsor ID
- CRD_856
- Conditions
- Heart Failure
- Keywords
- Negative, Atrioventricular, Hysteresis, Cardiac Resynchronization, MultiPoint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 25 May 2016 (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 evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT+NAVH | – | Device: CRT+NAVHSurface ECG and pressure-volume loop recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings at the device implant procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment will include patients scheduled to be implanted with MultiPoint Pacing-enabled SJM Quadripolar Pacing Systems
Key inclusion criteria (6 listed)
- Scheduled for implantation of an MPP-enabled SJM Quadripolar CRT Pacing System
- QRS duration > 140 ms
- Left bundle branch block documented
- Ability to provide informed consent for study participation
- Willing to comply with the study evaluation requirements
Key exclusion criteria (5 listed)
- Resting ventricular rate >100 bpm
- Intrinsic PR interval > 300 ms
- Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
- A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
- Women who are pregnant or who plan to become pregnant during the study
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 |
|---|---|---|
| CRT+NAVHCardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis | Device | CRT+NAVH |
Primary outcome
Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction
Time frame: 1 day
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy (CRT) with Negative Atrioventricular Hysteresis (NAVH) over a range of programmable values
2 secondary outcomes
Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction
Time frame: 1 day
Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction
Time frame: 1 day
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 10 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site in Italy.
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 5 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction (time frame: 1 day). 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 10 Jan 2024.