Cardiac Resynchronization TherapyCOMPACT-MPPNCT04299360
Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment
An observational study of Cardiac Resynchronization Therapy, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 3 sites in Italy.
Trial summary
Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- Cardiac Resynchronization Therapy device programming
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 3 sitesItaly
- Study dates
- 21 Nov 2016to 27 Feb 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: - Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria
Who may be able to join
- Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines
Who cannot join
- Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF
- NYHA IV patients
- Right Bundle Branch Block
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Ospedaliera Policlinico Mater Domini
Catanzaro, CZ, 88100
AO Cardarelli
Naples, 80100
AOU Federico II
Naples, 80100
About this study
Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- Cardiac Resynchronization Therapy device programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy device programmingDevice
Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively
| Study group | Role | What they receive |
|---|---|---|
| standard BIV | the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes. | |
| MPP BIV | Such modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation. Receives: Device: Cardiac Resynchronization Therapy device programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute improvement in cardiac function (1)
change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time.
Measured: 24-48 hours after CRT-D implantation
Acute improvement in cardiac function (2)
change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle.
Measured: 24-48 hours after CRT-D implantation
Secondary outcomes (2)
Delayed response (1)
change in GLS. Participants will investigate whether left ventricular remodeling upon "patient-tailored" biventricular stimulation will behave differentially according to type of stimulation; the total amount of CRT-responder patients will be therefore considered
Measured: 3 Months
Delayed response (2)
change in NYHA class. Participants will check if functional status will change after optimized biventricular stimulation therapy and will provide clinical data on CRT responders.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start21 Nov 2016
- Primary completion30 Oct 2019
- Study completion27 Feb 2020
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 Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Curcio, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299360
- Sponsor's protocol ID
- 178
- Acronym
- COMPACT-MPP
- Status last verified
- Mar 2020
- First submitted
- 12 Jul 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Passafaro F, Rapacciuolo A, Ruocco A, Ammirati G, Crispo S, Pasceri E, Santarpia G, Mauro C, Esposito G, Indolfi C, Curcio A. COMPArison of Multi-Point Pacing and ConvenTional Cardiac Resynchronization Therapy Through Noninvasive Hemodynamics Measurement: Short- and Long-Term Results of the COMPACT-MPP Study. Am J Cardiol. 2024 Mar 15;215:42-49. doi: 10.1016/j.amjcard.2023.12.057. Epub 2024 Jan 17.
PubMed 38237796
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment
- ClinicalTrials.gov ID
- NCT04299360
- Acronym / sponsor ID
- COMPACT-MPP / 178
- Conditions
- Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, CatanzaroUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 6 Mar 2020 (actual)
- 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.
Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard BIV | – | –the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes. |
| MPP BIV | – | Device: Cardiac Resynchronization Therapy device programmingSuch modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria
Key inclusion criteria (1 listed)
- Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines
Key exclusion criteria (3 listed)
- Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF
- NYHA IV patients
- Right Bundle Branch Block
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 |
|---|---|---|
| Cardiac Resynchronization Therapy device programmingImplanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively | Device | MPP BIV |
Primary outcome
Acute improvement in cardiac function (1)
Time frame: 24-48 hours after CRT-D implantation
change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time.
Acute improvement in cardiac function (2)
Time frame: 24-48 hours after CRT-D implantation
change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle.
2 secondary outcomes
Delayed response (1)
Time frame: 3 Months
Delayed response (2)
Time frame: 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 10 Mar 2020.
- Derived from this study: PubMed 38237796Passafaro F, Rapacciuolo A, Ruocco A, Ammirati G, Crispo S, Pasceri E, Santarpia G, Mauro C, Esposito G, Indolfi C, Curcio A. COMPArison of Multi-Point Pacing and ConvenTional Cardiac Resynchronization Therapy Through Noninvasive Hemodynamics Measurement: Short- and Long-Term Results of the COMPACT-MPP Study. Am J Cardiol. 2024 Mar 15;215:42-49. doi: 10.1016/j.amjcard.2023.12.057. Epub 2024 Jan 17.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Resynchronization Therapy, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 3 sites 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 1 inclusion and 3 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 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 improvement in cardiac function (1) (time frame: 24-48 hours after CRT-D implantation). The study lists 2 primary outcomes in all. 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 NCT04299360, 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 10 Mar 2020.