Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)Phase 4SYNCHRONCT02870647
Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
A Phase 4 study testing Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire in people with Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT), run by LivaNova at 3 sites in 2 countries.
Trial summary
Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
- What is being tested?
- Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Start not givento Mar 2020
- Phase
- Phase 4
- 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
Who may be able to join
- Patient successfully* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
- Signed and dated informed consent
- The subject will be available for postoperative follow-up beyond one year
Who cannot join
- Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
- Already included in another clinical study that could confound the results of this study
- Not available to attend routine follow-up visits
- Not able to understand the aim of the study and its procedures
- Minor age (according to local regulation)
- Drug / alcohol addiction or abuse
- Known pregnancy
- Under guardianship
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.
Read the detailed description
The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up.
The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.
Predictors of the clinical outcomes will be investigated.
- Being tested
- Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaireOther
each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | only 1 arm - no comparison nor randomization in this study Receives: Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).
Measured: 6 months
Secondary outcomes (1)
The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.
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 posted17 Aug 2016 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Strategy changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870647
- Sponsor's protocol ID
- ICSY03
- Acronym
- SYNCHRO
- Status last verified
- Nov 2017
- First submitted
- 15 Jul 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02870647
- Acronym / sponsor ID
- SYNCHRO / ICSY03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategy changes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 17 Aug 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.
Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.
Detailed description
The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up.
The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.
Predictors of the clinical outcomes will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaireonly 1 arm - no comparison nor randomization in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient successfully* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
- Signed and dated informed consent
- The subject will be available for postoperative follow-up beyond one year
Key exclusion criteria (8 listed)
- Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
- Already included in another clinical study that could confound the results of this study
- Not available to attend routine follow-up visits
- Not able to understand the aim of the study and its procedures
- Minor age (according to local regulation)
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 |
|---|---|---|
| Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaireeach patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months | Other | Single arm study |
Primary outcome
The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).
Time frame: 6 months
1 secondary outcome
The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire in people with Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT), run by LivaNova at 3 sites in 2 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 8 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: withdrawn, as of the sponsor's last update on 14 Nov 2017. 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 Spain, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade). (time frame: 6 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 14 Nov 2017.