Heart FailureE-OPTNCT01014000
Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate
A study testing Empirical group and Echocardiography-guided approach in people with Heart Failure and Cardiac Resynchronization Therapy, run by Princess Margaret Hospital, Hong Kong at 1 site in China.
Trial summary
Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. The response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy, Echocardiography
- What is being tested?
- Empirical group and Echocardiography-guided approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with SR or AF, indicated for CRT procedures (NYHA Class III or ambulatory Class IV despite optimal medical therapy, QRSd≥120ms and LVEF≤35%)
- Patients with ischaemic or non-ischaemic cardiomyopathy can be recruited
Who cannot join
- Patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement
- Patients who aged less than 18 or over 80.
- Patients who are pregnant.
- Patients who cannot give informed consent.
- Patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up.
- Patients who have comorbid congenital heart disease.
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- Patients who have severe valvular heart disease, apart from severe mitral regurgitation.
- Patients who have unstable angina or who are within 1 month of myocardial infarction.
- Patients who have severe lung disease and accurate clinical assessment for heart failure symptoms cannot be performed.
- Patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment, CRT procedures or follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. The response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. This study tested the hypothesis that echocardiography to assess acute resynchronization of the left ventricle during device implantation may improve the response rate to the therapy.
- Being tested
- Empirical group, Echocardiography-guided approach
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empirical groupDevice
Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
Echocardiography-guided approachDevice
Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
| Study group | Role | What they receive |
|---|---|---|
| Empirical | Active comparator | Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation Receives: Device: Empirical group |
| Echocardiography-guided approach | Experimental | Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation Receives: Device: Echocardiography-guided approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
Measured: 6 months after device implantation
Secondary outcomes (3)
Echocardiographic response of ≥15% reduction in LVESV
Measured: 6 months after device implantation
Echocardiographic response of absolute increase of ≥5% in LVEF
Measured: 6 months after device implantation
Biochemical response with reduction of BNP level≥15%
Measured: 6 months after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startJun 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: On reviewing of new data
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
- Investigators
- Ngai Yin Chan, MBBS, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014000
- Sponsor's protocol ID
- EOPT01
- Acronym
- E-OPT
- Status last verified
- Sep 2015
- First submitted
- 13 Nov 2009
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
- ClinicalTrials.gov ID
- NCT01014000
- Acronym / sponsor ID
- E-OPT / EOPT01
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: On reviewing of new data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Princess Margaret Hospital, Hong KongOther government
- Collaborators
- Medtronic
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 16 Nov 2009 (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.
Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. The response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. This study tested the hypothesis that echocardiography to assess acute resynchronization of the left ventricle during device implantation may improve the response rate to the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empirical | Active comparator | Device: Empirical groupEmpirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation |
| Echocardiography-guided approach | Experimental | Device: Echocardiography-guided approachEchocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with SR or AF, indicated for CRT procedures (NYHA Class III or ambulatory Class IV despite optimal medical therapy, QRSd≥120ms and LVEF≤35%)
- Patients with ischaemic or non-ischaemic cardiomyopathy can be recruited
Key exclusion criteria (10 listed)
- Patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement
- Patients who aged less than 18 or over 80.
- Patients who are pregnant.
- Patients who cannot give informed consent.
- Patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up.
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 |
|---|---|---|
| Empirical groupEmpirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation | Device | Empirical |
| Echocardiography-guided approachEchocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation | Device | Echocardiography-guided approach |
Primary outcome
Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
Time frame: 6 months after device implantation
3 secondary outcomes
Echocardiographic response of ≥15% reduction in LVESV
Time frame: 6 months after device implantation
Echocardiographic response of absolute increase of ≥5% in LVEF
Time frame: 6 months after device implantation
Biochemical response with reduction of BNP level≥15%
Time frame: 6 months after device implantation
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 4 Sep 2015.
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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.
Ngai Yin Chan, MBBS principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empirical group and Echocardiography-guided approach in people with Heart Failure and Cardiac Resynchronization Therapy, run by Princess Margaret Hospital, Hong Kong at 1 site in China.
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 10 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 4 Sep 2015. 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 China. 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 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?
Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT (time frame: 6 months after device implantation). 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 4 Sep 2015; AzTrials last refreshed its copy on 1 Nov 2026.