Heart FailurePhase 2NCT01035489
Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
A Phase 2 study testing CRT in heart failure; Right ventricular apex v.s. high posterior septum in people with Heart Failure, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT in heart failure; Right ventricular apex v.s. high posterior septum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Jun 2012
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRT:
- LVEF < 35%
- LVEDD > 5.5 cm
- NYHA 3-4
- QRS > 120 ms
- Optimal medical treatment
- Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D)
Who cannot join
- Not fulfilling inclusion criteria or not written consensus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.
- Conditions
- Heart Failure
- Being tested
- CRT in heart failure; Right ventricular apex v.s. high posterior septum
- Keywords
- Pacemaker treatment in heart failure, Cardiac resynchronization therapy, DDD pacemakers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT in heart failure; Right ventricular apex v.s. high posterior septumDevice
RV lead is randomized to either apex or high posterior septum
CRT in heart failure; Right ventricular apex v.s. high posterior septumDevice
RV lead is randomized to either apex or high posterior septum
| Study group | Role | What they receive |
|---|---|---|
| CRT; RV apical lead placement | Active comparator | Right ventricular apical lead placement in CRT Receives: Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum |
| CRT; RV high posterior septum | Active comparator | High posterior septal lead placement in CRT Receives: Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic reverse remodelling and dyssynchrony
Measured: 3, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Svein Faerestrand, MD, PhD, Principal investigator, Faerestrand S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035489
- Sponsor's protocol ID
- 2009/1991
- Status last verified
- May 2011
- First submitted
- 17 Dec 2009
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. The impact of left ventricular lead position on left ventricular reverse remodelling and improvement in mechanical dyssynchrony in cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging. 2012 Dec;13(12):991-1000. doi: 10.1093/ehjci/jes114. Epub 2012 Jun 7.
PubMed 22677455Kristiansen HM, Hovstad T, Vollan G, Keilegavlen H, Faerestrand S. Clinical implication of right ventricular to left ventricular interlead sensed electrical delay in cardiac resynchronization therapy. Europace. 2012 Jul;14(7):986-93. doi: 10.1093/europace/eur429. Epub 2012 Feb 2.
PubMed 22308084Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. A randomized study of haemodynamic effects and left ventricular dyssynchrony in right ventricular apical vs. high posterior septal pacing in cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):506-16. doi: 10.1093/eurjhf/hfr162. Epub 2012 Jan 26.
PubMed 22286156
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
- ClinicalTrials.gov ID
- NCT01035489
- Acronym / sponsor ID
- 2009/1991
- Conditions
- Heart Failure
- Keywords
- Pacemaker treatment in heart failure, Cardiac resynchronization therapy, DDD pacemakers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 18 Dec 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.
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT; RV apical lead placement | Active comparator | Device: CRT in heart failure; Right ventricular apex v.s. high posterior septumRight ventricular apical lead placement in CRT |
| CRT; RV high posterior septum | Active comparator | Device: CRT in heart failure; Right ventricular apex v.s. high posterior septumHigh posterior septal lead placement in CRT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- CRT:
Key exclusion criteria (1 listed)
- Not fulfilling inclusion criteria or not written consensus
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 |
|---|---|---|
| CRT in heart failure; Right ventricular apex v.s. high posterior septumRV lead is randomized to either apex or high posterior septum | Device | CRT; RV apical lead placement |
| CRT in heart failure; Right ventricular apex v.s. high posterior septumRV lead is randomized to either apex or high posterior septum | Device | CRT; RV high posterior septum |
Primary outcome
Echocardiographic reverse remodelling and dyssynchrony
Time frame: 3, 6, 12, 18 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
- Derived from this study: PubMed 22677455Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. The impact of left ventricular lead position on left ventricular reverse remodelling and improvement in mechanical dyssynchrony in cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging. 2012 Dec;13(12):991-1000. doi: 10.1093/ehjci/jes114. Epub 2012 Jun 7.
- Derived from this study: PubMed 22308084Kristiansen HM, Hovstad T, Vollan G, Keilegavlen H, Faerestrand S. Clinical implication of right ventricular to left ventricular interlead sensed electrical delay in cardiac resynchronization therapy. Europace. 2012 Jul;14(7):986-93. doi: 10.1093/europace/eur429. Epub 2012 Feb 2.
- Derived from this study: PubMed 22286156Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. A randomized study of haemodynamic effects and left ventricular dyssynchrony in right ventricular apical vs. high posterior septal pacing in cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):506-16. doi: 10.1093/eurjhf/hfr162. Epub 2012 Jan 26.
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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.
Svein Faerestrand, MD, PhD principal investigator
Faerestrand S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRT in heart failure; Right ventricular apex v.s. high posterior septum in people with Heart Failure, run by Haukeland University Hospital at 1 site in Norway.
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 1 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 24 May 2011. 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 Norway. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Echocardiographic reverse remodelling and dyssynchrony (time frame: 3, 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01035489, which also lists 3 linked publications.
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 24 May 2011.