Image Guided Mapping for Cardiac Pacing Intervention (MAPIT-TOO)
|ClinicalTrials.gov Identifier: NCT01638754|
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Procedure: Image guided Cardiac Resynchronization Therapy (CRT) device lead placement. Procedure: optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Modality Imaging Assessment for Pacing Interventions in Heart Failure: Targeting Optimal Sites and Outcomes|
|Actual Study Start Date :||May 1, 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 18, 2014|
Procedure: Image guided Cardiac Resynchronization Therapy (CRT) device lead placement.
- improvement in LVESV by greater than/equal to 15% [ Time Frame: 3-6 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638754
|London Health Sciences Centre|
|London, Ontario, Canada, N6A5A5|
|Principal Investigator:||James White, MD, FRCPC||Lawson Health Research Institute|