Heart Failure With Intraventricular Conduction DelayNCT02247817
A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
A study testing Hybrid CRT-D/P implantation in people with Heart Failure With Intraventricular Conduction Delay, run by University Medical Center Groningen.
Trial summary
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Intraventricular Conduction Delay
- What is being tested?
- Hybrid CRT-D/P implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA class II-III.
- Left ventricular ejection fraction ≤ 35%.
- QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology.
- No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
- On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists.
- Age ≥ 18 years.
- Signed informed consent.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Coronary ischemia or a recent myocardial infarction (< 6 months).
- Allready a CRT-device implanted.
- Venous thrombosis without options to reach the right heart.
- Presence of any other condition than HF with a life expectancy of < 1 year.
- History of intrathoracic surgery.
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- Presence or suspected presence of a noncompliant left lung.
- Participation in another intervention trial.
- Unable to understand Dutch language.
- Pregnant women.
About this study
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.
- Being tested
- Hybrid CRT-D/P implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid CRT-D/P implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| HYBRID | Experimental | Hybrid transvenous/epicardial implantation of a CRT-(D) device. Receives: Device: Hybrid CRT-D/P implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedure related serious adverse events
Measured: 30 days after implantation of device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Intraventricular Conduction DelayStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper J. Schouwenburg, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247817
- Sponsor's protocol ID
- METc 2013/387
- Status last verified
- Sep 2014
- First submitted
- 20 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT02247817
- Acronym / sponsor ID
- METc 2013/387
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 25 Sep 2014 (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.
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYBRID | Experimental | Device: Hybrid CRT-D/P implantationHybrid transvenous/epicardial implantation of a CRT-(D) device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- NYHA class II-III.
- Left ventricular ejection fraction ≤ 35%.
- QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology.
- No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
- On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists.
Key exclusion criteria (10 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Coronary ischemia or a recent myocardial infarction (< 6 months).
- Allready a CRT-device implanted.
- Venous thrombosis without options to reach the right heart.
- Presence of any other condition than HF with a life expectancy of < 1 year.
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 |
|---|---|---|
| Hybrid CRT-D/P implantation | Device | HYBRID |
Primary outcome
Number of procedure related serious adverse events
Time frame: 30 days after implantation of device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid CRT-D/P implantation in people with Heart Failure With Intraventricular Conduction Delay, run by University Medical Center Groningen.
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 7 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: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of procedure related serious adverse events (time frame: 30 days after implantation of device). 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 25 Sep 2014.