Heart Failure, UnspecifiedNCT03001141
Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
An observational study of Heart Failure, Unspecified, run by Abbott Medical Devices at 4 sites in Brazil.
Trial summary
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Unspecified
- What is being tested?
- Observational
- How many people
- 200 participants
- Where
- 4 sitesBrazil
- Study dates
- 18 May 2017to 8 Feb 2019
- How long will I take part?
- 12 Months
- 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: Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study. Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.
Who may be able to join
- Patient willing and able to sign Informed Consent Form
- Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability
Who cannot join
- Is likely to undergo a heart transplantation within 12 months
- Is less than 18 years old
- Is pregnant or is planning to get pregnant during the study
- Is currently taking part in a Clinical Trial with an active treatment group
- Life expectancy is under 6 months
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Clinica Dom Rodrigo
João Pessoa, Paraíba
BP
São Paulo, São Paulo, 01323-001
Instituto de Arritmias Cardíacas
São Paulo, São Paulo, 01323-001
SEMAP
São Paulo, São Paulo, 04.004-030
About this study
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers.
Read the detailed description
Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study.
Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.
- Conditions
- Heart Failure, Unspecified
- Being tested
- Observational
- Keywords
- MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, Quadripolar pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.
| Study group | Role | What they receive |
|---|---|---|
| Single group - observational | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac resynchronization therapy response rate measured by Clinical Composite Score
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Secondary outcomes (7)
Quality of Life changes, measured by MLWHF questionnaire
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Quality of Life changes, measured by EQ-5D questionnaire
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Change in left ventricular ejection fraction
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Change in left ventricular end systolic volume
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Programming strategy used (vector and intervals), obtained from the Device Session records
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Heart failure hospitalization rate
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
All-cause mortality
Evaluated on regular medical visits and registered in the CRF
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start18 May 2017
- Primary completion18 Apr 2018
- Study completion8 Feb 2019
Why it stopped: Ethic Comitte (CONEP) determinated the prematurely terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, UnspecifiedStudies 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
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Aurelio Santos, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001141
- Sponsor's protocol ID
- U1111-1190-5280
- Status last verified
- Sep 2019
- First submitted
- 20 Dec 2016
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol/ Registry of MultiPoint™ Pacing in Brazil
- ClinicalTrials.gov ID
- NCT03001141
- Acronym / sponsor ID
- U1111-1190-5280
- Conditions
- Heart Failure, Unspecified
- Keywords
- MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, Quadripolar pacing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ethic Comitte (CONEP) determinated the prematurely terminated.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 22 Dec 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.
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers.
Detailed description
Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study.
Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group - observational | – | Other: Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study. Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.
Key inclusion criteria (2 listed)
- Patient willing and able to sign Informed Consent Form
- Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability
Key exclusion criteria (5 listed)
- Is likely to undergo a heart transplantation within 12 months
- Is less than 18 years old
- Is pregnant or is planning to get pregnant during the study
- Is currently taking part in a Clinical Trial with an active treatment group
- Life expectancy is under 6 months
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 |
|---|---|---|
| ObservationalDevice: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician. | Other | Single group - observational |
Primary outcome
Cardiac resynchronization therapy response rate measured by Clinical Composite Score
Time frame: 12 months
Evaluated on regular medical visits and registered in the CRF
7 secondary outcomes
Quality of Life changes, measured by MLWHF questionnaire
Time frame: 12 months
Quality of Life changes, measured by EQ-5D questionnaire
Time frame: 12 months
Change in left ventricular ejection fraction
Time frame: 12 months
Change in left ventricular end systolic volume
Time frame: 12 months
Programming strategy used (vector and intervals), obtained from the Device Session records
Time frame: 12 months
Heart failure hospitalization rate
Time frame: 12 months
All-cause mortality
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Ethic Comitte (CONEP) determinated the prematurely terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Marco Aurelio Santos study director
Abbott Medical Devices
4 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, Unspecified, run by Abbott Medical Devices at 4 sites in Brazil.
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 2 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: stopped early, as of the sponsor's last update on 16 Sep 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 Brazil. 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: Ethic Comitte (CONEP) determinated the prematurely terminated.). 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?
Cardiac resynchronization therapy response rate measured by Clinical Composite Score (time frame: 12 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 16 Sep 2019.