Heart FailureRECOVERNCT04397224
Reduction or Extension of COnduction Time With Ventricular Electromechanical Remodeling (RECOVER)
An observational study of Heart Failure, run by Samsung Medical Center at 6 sites in South Korea.
Trial summary
This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Device interrogation
- How many people
- 100 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 20 Jul 2018to 20 Jul 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients implanted with multipoint pacing CRT device and quadripolar left ventricular lead from Abbott
Who may be able to join
- meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant
Who cannot join
- Myocardial infarction, unstable angina within 40 days prior the enrollment
- Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
- Primary valvular disease requiring surgical correction
- Pregnant or are planning during the duration of the investigation
- Status 1 candidate for cardiac transplantation or consideration for transplantation over the next 12 months
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- Post-cardiac transplantation
- Life expectancy < 12 months
- Currently participating in any other clinical investigation except for observational registry
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Sejong General Hospital
Bucheon-si
Sang Weon Park
- Recruiting
Samsung Changwon Medical Center
Changwon
Hye Bin Gwag, +82-55-2335821, tgfbk@naver.com
- Recruiting
Chungnam National University Hospital
Daejeon
Jun-Hyung Kim
- Recruiting
Eulji University Hospital
Daejeon
Ki-Woon Kang
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Il-young Oh
- Recruiting
Samsung Medical Center
Seoul
Seung-Jung Park, +82-2-3410-7145, orthovics@gmail.com
About this study
Official title: Prospective Multicenter Observation Study on the Serial Changes in Ventriculo-ventricular Conduction Times According to Cardiac-resynchronization Therapy Response
This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.
- Conditions
- Heart Failure
- Being tested
- Device interrogation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device interrogationDiagnostic test
Ventriculo-ventricular conduction time measurement using device analyzer
| Study group | Role | What they receive |
|---|---|---|
| CRT responder | Not described Receives: Diagnostic Test: Device interrogation | |
| CRT non-responder | Not described Receives: Diagnostic Test: Device interrogation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial change of ventriculo-ventricular conduction times
Reduction or extension of ventriculo-ventricular conduction times
Measured: from enrollment to last follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start20 Jul 2018
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2024 (estimated)
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 Samsung Medical CenterThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397224
- Sponsor's protocol ID
- 2018-05-073
- Acronym
- RECOVER
- Status last verified
- Jun 2021
- First submitted
- 17 May 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observation Study on the Serial Changes in Ventriculo-ventricular Conduction Times According to Cardiac-resynchronization Therapy Response
- ClinicalTrials.gov ID
- NCT04397224
- Acronym / sponsor ID
- RECOVER / 2018-05-073
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 21 May 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.
This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT responder | – | Diagnostic Test: Device interrogation |
| CRT non-responder | – | Diagnostic Test: Device interrogation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients implanted with multipoint pacing CRT device and quadripolar left ventricular lead from Abbott
Key inclusion criteria (1 listed)
- meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant
Key exclusion criteria (9 listed)
- Myocardial infarction, unstable angina within 40 days prior the enrollment
- Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
- Primary valvular disease requiring surgical correction
- Pregnant or are planning during the duration of the investigation
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 |
|---|---|---|
| Device interrogationVentriculo-ventricular conduction time measurement using device analyzer | Diagnostic test | CRT non-responder, CRT responder |
Primary outcome
Serial change of ventriculo-ventricular conduction times
Time frame: from enrollment to last follow-up (2 years)
Reduction or extension of ventriculo-ventricular conduction times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- 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.
6 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, run by Samsung Medical Center at 6 sites in South Korea.
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 9 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: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Jung Park (+82-2-3410-7145, orthovics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial change of ventriculo-ventricular conduction times (time frame: from enrollment to last follow-up (2 years)). 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 30 Jun 2021.