Heart FailureMAPIT-TOONCT01638754
Image Guided Mapping for Cardiac Pacing Intervention
A study testing Image guided Cardiac Resynchronization Therapy (CRT) device lead placement. and optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices in people with Heart Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with heart failure and cardiomyopathy that have been referred for Cardiac Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided treatment plan for optimal lead delivery. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Image guided Cardiac Resynchronization Therapy (CRT) device lead placement. and optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2011to 18 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient (> or equal to 40 years old) referred for cardiac resynchronization therapy
- New York Heart Association (NYHA) greater than or equal to 2
- ejection fraction </=35%
- QRS duration >/=120 msec
- Patient has been on stable heart failure medications for at least 6 weeks and in the investigator's opinion reached optimal medical therapy for treatment of heart failure over the past 6 months
Who cannot join
- patients with contraindications to MRI
- recent myocardial infarction within last 6 weeks
- cardiac revascularization procedure within the past 3 months
- glomerular filtration rate (GFR) </= 30ml/min/m2
- unable to give informed consent
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Modality Imaging Assessment for Pacing Interventions in Heart Failure: Targeting Optimal Sites and Outcomes
Patients with heart failure and cardiomyopathy that have been referred for Cardiac Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided treatment plan for optimal lead delivery. The validation of image-guided CRT lead delivery will significantly advance the field of heart failure therapy.
Read the detailed description
Objective 1: Using established study data from our previous study (Multimodality imaging Assessment of Pacing InTervention in Heart Failure Heart Failure or MAPIT HF) define characteristics of the "optimal myocardial target" that maximally yields clinical response to CRT.
Objective 2: Using established MAPIT-HF study data identify whether alternate coronary venous pathways to "optimal myocardial targets" exists in clinical non-responders.
Objective 3: Evaluate the feasibility of guiding the delivery of CRT leads to "optimal myocardial targets" through the use of an interactive, 3D "integrated cardiac model" of coronary vein anatomy, myocardial scar and mechanical dyssynchrony.
Currently there is no standard definition for response to CRT. Of importance is that measures of clinical response appear to be incongruent with echocardiographic parameters of reverse remodeling following CRT. The primary endpoint of clinical response will be an improvement in Left ventricular end systolic volume (LVESV) by ≥ 15% at 3 months following CRT, as validated in prior studies. Secondary clinical endpoints will also be evaluated; 1) Improvement in ejection fraction ≥ 5 percentage points, 2) Improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%, 3) Improvement in NYHA (New York Heart Association) functional class by 1, or Specific Activity Score by 1, and 4) Improvement in Quality of Life (Minnesota Living with Heart Failure) by 10 points.
Our hypothesis is that a single 3D dataset can be developed from multiple MRI datasets for the simultaneous display of coronary venous anatomy, myocardial scar, and mechanical dyssynchrony, the latter being derived from tagged MRI data. The investigators hypothesize that the availability of this 3D model during fluoroscopic CRT lead placement will result in improved rates of lead tip delivery to "optimal myocardial targets" and improved clinical response. Our specific hypotheses of Project 2 are as follows;
- The generation of an integrated cardiac model of venous anatomy, myocardial scar and dyssynchrony is feasible using multiple MRI-derived datasets.
- The availability of this interactive 3D cardiac model during fluoroscopic CRT lead delivery will increase the occurrence of CRT lead tips being delivered to "optimal myocardial segments" when compared to historic control data within the MAPIT-HF study cohort.
- Conditions
- Heart Failure
- Being tested
- Image guided Cardiac Resynchronization Therapy (CRT) device lead placement., optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image guided Cardiac Resynchronization Therapy (CRT) device lead placement.Procedure or surgery
Participants will have a cardiac MRI scan prior to insertion of CRT device and an image guided map will be created to guide placement of Cardiac Resynchronization Therapy (CRT) pacing leads to the most optimal target on the patients heart.
optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devicesProcedure or surgery
optimal lead placement will be determined by 3D model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in LVESV by greater than/equal to 15%
Measured: 3-6 months
Secondary outcomes (4)
improvement in ejection fraction greater than or equal to 5%,
Measured: 3-6 months
improvement in 6 minute walk equal to or greater than 30 meters
Measured: 3-6 months
improvement in NYHA functional class by 1
Measured: 3-6 months
improved QoL by 10 points
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study start1 May 2011
- Primary completionAug 2014
- Study completion18 Dec 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James White, MD, FRCPC, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638754
- Sponsor's protocol ID
- R-11-074
- Other IDs
- 17696
- Acronym
- MAPIT-TOO
- Status last verified
- Nov 2017
- First submitted
- 29 Jun 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modality Imaging Assessment for Pacing Interventions in Heart Failure: Targeting Optimal Sites and Outcomes
- ClinicalTrials.gov ID
- NCT01638754
- Acronym / sponsor ID
- MAPIT-TOO / R-11-074
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- 18 Dec 2014 (actual)
- First posted
- 12 Jul 2012 (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.
Patients with heart failure and cardiomyopathy that have been referred for Cardiac Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided treatment plan for optimal lead delivery. The validation of image-guided CRT lead delivery will significantly advance the field of heart failure therapy.
Detailed description
Objective 1: Using established study data from our previous study (Multimodality imaging Assessment of Pacing InTervention in Heart Failure Heart Failure or MAPIT HF) define characteristics of the "optimal myocardial target" that maximally yields clinical response to CRT.
Objective 2: Using established MAPIT-HF study data identify whether alternate coronary venous pathways to "optimal myocardial targets" exists in clinical non-responders.
Objective 3: Evaluate the feasibility of guiding the delivery of CRT leads to "optimal myocardial targets" through the use of an interactive, 3D "integrated cardiac model" of coronary vein anatomy, myocardial scar and mechanical dyssynchrony.
Currently there is no standard definition for response to CRT. Of importance is that measures of clinical response appear to be incongruent with echocardiographic parameters of reverse remodeling following CRT. The primary endpoint of clinical response will be an improvement in Left ventricular end systolic volume (LVESV) by ≥ 15% at 3 months following CRT, as validated in prior studies. Secondary clinical endpoints will also be evaluated; 1) Improvement in ejection fraction ≥ 5 percentage points, 2) Improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%, 3) Improvement in NYHA (New York Heart Association) functional class by 1, or Specific Activity Score by 1, and 4) Improvement in Quality of Life (Minnesota Living with Heart Failure) by 10 points.
Our hypothesis is that a single 3D dataset can be developed from multiple MRI datasets for the simultaneous display of coronary venous anatomy, myocardial scar, and mechanical dyssynchrony, the latter being derived from tagged MRI data. The investigators hypothesize that the availability of this 3D model during fluoroscopic CRT lead placement will result in improved rates of lead tip delivery to "optimal myocardial targets" and improved clinical response. Our specific hypotheses of Project 2 are as follows;
- The generation of an integrated cardiac model of venous anatomy, myocardial scar and dyssynchrony is feasible using multiple MRI-derived datasets.
- The availability of this interactive 3D cardiac model during fluoroscopic CRT lead delivery will increase the occurrence of CRT lead tips being delivered to "optimal myocardial segments" when compared to historic control data within the MAPIT-HF study cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- any patient (> or equal to 40 years old) referred for cardiac resynchronization therapy
- New York Heart Association (NYHA) greater than or equal to 2
- ejection fraction </=35%
- QRS duration >/=120 msec
- Patient has been on stable heart failure medications for at least 6 weeks and in the investigator's opinion reached optimal medical therapy for treatment of heart failure over the past 6 months
Key exclusion criteria (6 listed)
- patients with contraindications to MRI
- recent myocardial infarction within last 6 weeks
- cardiac revascularization procedure within the past 3 months
- glomerular filtration rate (GFR) </= 30ml/min/m2
- unable to give informed consent
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 |
|---|---|---|
| Image guided Cardiac Resynchronization Therapy (CRT) device lead placement.Participants will have a cardiac MRI scan prior to insertion of CRT device and an image guided map will be created to guide placement of Cardiac Resynchronization Therapy (CRT) pacing leads to the most optimal target on the patients heart. | Procedure or surgery | – |
| optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devicesoptimal lead placement will be determined by 3D model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony | Procedure or surgery | – |
Primary outcome
improvement in LVESV by greater than/equal to 15%
Time frame: 3-6 months
4 secondary outcomes
improvement in ejection fraction greater than or equal to 5%,
Time frame: 3-6 months
improvement in 6 minute walk equal to or greater than 30 meters
Time frame: 3-6 months
improvement in NYHA functional class by 1
Time frame: 3-6 months
improved QoL by 10 points
Time frame: 3-6 months
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 6 Nov 2017.
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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.
James White, MD, FRCPC principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided Cardiac Resynchronization Therapy (CRT) device lead placement. and optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices in people with Heart Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 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 6 Nov 2017. 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 Canada. 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?
improvement in LVESV by greater than/equal to 15% (time frame: 3-6 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 6 Nov 2017; AzTrials last refreshed its copy on 28 Oct 2026.