Heart FailureIDEAL-CRTNCT02061241
A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation Therapy
An observational study of Heart Failure, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacing in vein at site of latest mechanical activation and Pacing in other suitable vein
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Due to have CRT device implants.
Who may be able to join
- With ejection fraction <35%
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Indication for cardiac resynchronisation therapy
Who cannot join
- Left Ventricular Ejection Fraction >35%
- Severe peripheral vascular disease (that would make arterial access more risky)
- Haemodynamic instability (such that a longer procedure is inadvisable)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7AT
About this study
Official title: Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT
Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT.
Targeting the position of the left ventricular (LV) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT. Several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP occurs. Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information.
Read more
The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR. It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed.
This study will also be able to contribute towards several important secondary questions. In particular the investigators will study the possibility of using non-invasive cardiac output monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure monitor wire. The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.
- Conditions
- Heart Failure
- Being tested
- Pacing in vein at site of latest mechanical activation, Pacing in other suitable vein
- Keywords
- Cardiac resynchronisation therapy, Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing in vein at site of latest mechanical activationProcedure or surgery
Pacing in vein at site of latest mechanical activation
Pacing in other suitable veinProcedure or surgery
Pacing in other suitable vein
| Study group | Role | What they receive |
|---|---|---|
| Patients | All included patients, having CRT implant procedure Will have both Pacing in vein at site of latest mechanical activation and Pacing in other suitable vein. Receives: Procedure: Pacing in vein at site of latest mechanical activation; Procedure: Pacing in other suitable vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute haemodynamic response in area of latest mechanical activation and another vein
To assess whether pacing at the site of latest mechanical activation produces the maximal acute haemodynamic response to biventricular pacing, when compared to other attainable Left Ventricular coronary venous pacing sites.
Acute haemodynamic response measured as percentage change in left ventricular dP/dt max (maximum rate of change of left ventricular pressure) recorded by a left ventricular pressure wire, between baseline atrial pacing at 80 beats per minute and biventricular pacing in each vein
Measured: Time 0 (during implant procedure)
Secondary outcomes (3)
Maximum acute haemodynamic response between all available pacing vectors in the vein within the area of latest mechanical response
To assess if further increases in acute haemodynamic response at the site of latest mechanical activation can be achieved with different pacing configurations.
Measured: Time 0 (during implant procedure)
Acute haemodynamic response by NICOM and pressure wire
To compare results attained from non-invasive cardiac output monitoring (NICOM) to those from invasive monitoring
Measured: Time 0 (during implant procedure)
Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm
To assess the effect of right ventricular pacing on the site of latest mechanical activation. Assessed using speckle-tracking echocardiography.
Measured: 1 day post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Dr James Gamble, Oxford University Hospitals NHS Trust
- Investigators
- Tim R Betts, MBChB, MD, Principal investigator, Oxford University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061241
- Sponsor's protocol ID
- NIHR CSP 146533
- Other IDs
- 14/SC/0148
- Acronym
- IDEAL-CRT
- Status last verified
- Oct 2015
- First submitted
- 7 Feb 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.
PubMed 22405632McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. doi: 10.1001/jama.297.22.2502.
PubMed 17565085Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.
PubMed 23476053Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042.
PubMed 21884950
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT
- ClinicalTrials.gov ID
- NCT02061241
- Acronym / sponsor ID
- IDEAL-CRT / NIHR CSP 146533
- Conditions
- Heart Failure
- Keywords
- Cardiac resynchronisation therapy, Pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Feb 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 resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT.
Targeting the position of the left ventricular (LV) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT. Several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP occurs. Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information.
The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR. It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed.
This study will also be able to contribute towards several important secondary questions. In particular the investigators will study the possibility of using non-invasive cardiac output monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure monitor wire. The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Pacing in vein at site of latest mechanical activation, Procedure: Pacing in other suitable veinAll included patients, having CRT implant procedure Will have both Pacing in vein at site of latest mechanical activation and Pacing in other suitable vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Due to have CRT device implants.
Key inclusion criteria (4 listed)
- With ejection fraction <35%
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Indication for cardiac resynchronisation therapy
Key exclusion criteria (3 listed)
- Left Ventricular Ejection Fraction >35%
- Severe peripheral vascular disease (that would make arterial access more risky)
- Haemodynamic instability (such that a longer procedure is inadvisable)
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 |
|---|---|---|
| Pacing in vein at site of latest mechanical activationPacing in vein at site of latest mechanical activation | Procedure or surgery | Patients |
| Pacing in other suitable veinPacing in other suitable vein | Procedure or surgery | Patients |
Primary outcome
Acute haemodynamic response in area of latest mechanical activation and another vein
Time frame: Time 0 (during implant procedure)
To assess whether pacing at the site of latest mechanical activation produces the maximal acute haemodynamic response to biventricular pacing, when compared to other attainable Left Ventricular coronary venous pacing sites. Acute haemodynamic response measured as percentage change in left ventricular dP/dt max (maximum rate of change of left ventricular pressure) recorded by a left ventricular pressure wire, between baseline atrial pacing at 80 beats per minute and biventricular pacing in each vein
3 secondary outcomes
Maximum acute haemodynamic response between all available pacing vectors in the vein within the area of latest mechanical response
Time frame: Time 0 (during implant procedure)
Acute haemodynamic response by NICOM and pressure wire
Time frame: Time 0 (during implant procedure)
Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm
Time frame: 1 day post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Background: PubMed 22405632Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.
- Background: PubMed 17565085McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. doi: 10.1001/jama.297.22.2502.
- Background: PubMed 23476053Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.
- Background: PubMed 21884950Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Tim R Betts, MBChB, MD principal investigator
Oxford University Hospitals
1 site 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 Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Oct 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute haemodynamic response in area of latest mechanical activation and another vein (time frame: Time 0 (during implant procedure)). 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 NCT02061241, which also lists 4 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 20 Oct 2015.