Image Guided Mapping for Cardiac Pacing Intervention (MAPIT-TOO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Lawson Health Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
James White, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01638754
First received: June 29, 2011
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Heart Failure
Procedure: Image guided Cardiac Resynchronization Therapy (CRT) device lead placement.
Procedure: optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Modality Imaging Assessment for Pacing Interventions in Heart Failure: Targeting Optimal Sites and Outcomes

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • improvement in LVESV by greater than/equal to 15% [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement in ejection fraction greater than or equal to 5%, [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • improvement in 6 minute walk equal to or greater than 30 meters [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • improvement in NYHA functional class by 1 [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • improved QoL by 10 points [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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: optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices
    optimal lead placement will be determined by 3D model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony
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;

  1. The generation of an integrated cardiac model of venous anatomy, myocardial scar and dyssynchrony is feasible using multiple MRI-derived datasets.
  2. 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.
  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638754

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: James White, MD, FRCPC Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: James White, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01638754     History of Changes
Other Study ID Numbers: R-11-074, 17696
Study First Received: June 29, 2011
Last Updated: July 11, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014