Heart FailurePhase 2/3NCT01429753
PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial
A Phase 2/3 study testing Advanced Imaging Guided LV lead placement and Standard LV lead placement in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by… 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?
- Advanced Imaging Guided LV lead placement and Standard LV lead placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Apr 2014
- Phase
- Phase 2/3
- 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
- >18yrs of age
- Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS >120ms and significant LV dysfunction LEF <35%)
- Stable on optimal medical therapy for at least 3 months
- No exclusion to pacing /ICD
- Ischaemic or non-ischaemic aetiology
Who cannot join
- Any contraindication to pacing /ICD implant
- Contraindication to MR scanning
- Claustrophobia
- Significant renal impairment (estimated GFR <30)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomised Study of Advanced Imaging Guided Cardiac Resynchronisation Therapy (CRT) vs Conventional CRT Implantation in Patients With Chronic Heart Failure
Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.
- Conditions
- Heart Failure
- Being tested
- Advanced Imaging Guided LV lead placement, Standard LV lead placement
- Keywords
- Cardiac resychronisation therapy, Heart failure, Imaging guided LV lead placement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Imaging Guided LV lead placementOther
Use of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time.
Standard LV lead placementDevice
Standard LV lead placement not guided by advanced imaging
| Study group | Role | What they receive |
|---|---|---|
| Standard LV lead placement | Active comparator | Not described Receives: Device: Standard LV lead placement |
| Advanced Imaging Guided LV Lead Placement | Experimental | Not described Receives: Other: Advanced Imaging Guided LV lead placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of CRT responders
Measured: 6 months
Secondary outcomes (7)
Change in echo derived end systolic (ESV) and diastolic volumes
Measured: 6 months
Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)
Measured: 6 months
Procedural success
Measured: 0 months
Procedure duration
Measured: 0 months
Radiation dose
Measured: 0 months
Contrast dose
Measured: 0 months
Procedural complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (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 Guy's and St Thomas' NHS Foundation TrustThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Christopher Aldo Rinaldi, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429753
- Sponsor's protocol ID
- 09/H0802/126
- Status last verified
- Sep 2011
- First submitted
- 5 Sep 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study of Advanced Imaging Guided Cardiac Resynchronisation Therapy (CRT) vs Conventional CRT Implantation in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01429753
- Acronym / sponsor ID
- 09/H0802/126
- Conditions
- Heart Failure
- Keywords
- Cardiac resychronisation therapy, Heart failure, Imaging guided LV lead placement
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 7 Sep 2011 (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) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard LV lead placement | Active comparator | Device: Standard LV lead placement |
| Advanced Imaging Guided LV Lead Placement | Experimental | Other: Advanced Imaging Guided LV lead placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18yrs of age
- Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS >120ms and significant LV dysfunction LEF <35%)
- Stable on optimal medical therapy for at least 3 months
- No exclusion to pacing /ICD
- Ischaemic or non-ischaemic aetiology
Key exclusion criteria (4 listed)
- Any contraindication to pacing /ICD implant
- Contraindication to MR scanning
- Claustrophobia
- Significant renal impairment (estimated GFR <30)
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 |
|---|---|---|
| Advanced Imaging Guided LV lead placementUse of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time. | Other | Advanced Imaging Guided LV Lead Placement |
| Standard LV lead placementStandard LV lead placement not guided by advanced imaging | Device | Standard LV lead placement |
Primary outcome
Change in the proportion of CRT responders
Time frame: 6 months
7 secondary outcomes
Change in echo derived end systolic (ESV) and diastolic volumes
Time frame: 6 months
Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)
Time frame: 6 months
Procedural success
Time frame: 0 months
Procedure duration
Time frame: 0 months
Radiation dose
Time frame: 0 months
Contrast dose
Time frame: 0 months
Procedural complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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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.
Christopher Aldo Rinaldi, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Advanced Imaging Guided LV lead placement and Standard LV lead placement in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust.
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 5 inclusion and 4 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 7 Sep 2011. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Manav Sohal, MBBS (+442071887188, manav.sohal@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion of CRT responders (time frame: 6 months). 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 7 Sep 2011; AzTrials last refreshed its copy on 2 Nov 2026.