Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Systolic Heart Failure Clinical Trial

Official title:

MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01640769
• Other study ID #: MAPIT-CRT
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 9, 2012
• Last updated: July 11, 2012
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: July 2012
• Source: Lawson Health Research Institute
• Contact: Kristine Carter, RN
• Phone: 519-685-8300
• Email: kris.carter[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Magnetic Resonance Image guided delivery of Left and Right Ventricular Leads to optimal myocardial targets will result in improved clinical response to CRT using Left Ventricular remodeling criteria.

Description:

Cardiac Dyssynchrony and scar are important variables for realization of clinical response to cardiac resynchronization therapy (CRT). Results from a previous study suggest that paced heart segment characteristics do predict this response and our ability to identify venous pathways to optimal segments is feasible using cardiac CT and MRI. In an ongoing feasibility study we are using these capabilities to guide the delivery of CRT lead systems to optimal myocardial targets. A computer software program has been developed that can create an interactive, 3D integrated cardiac model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony. Although this feasibility study is ongoing, early results show this method of guiding the CRT leads to optimal targets with these individualized models to be safe and effective.

This trial will be a larger multi-centre randomized blinded trial to determine the therapeutic impact of MRI guided Left Ventricular and Right Ventricular lead placement with respect to improving clinical response rates for CRT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 328
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. Ejection fraction = 35 %.

3. QRS duration = 120 msec.

4. NYHA class II-IV.

5. On maximum tolerated heart failure medication therapy = 6 weeks.

6. Clinically accepted for CRT device implantation.

Exclusion Criteria:

1. Failure to provide consent.

2. CCS class III-IV angina.

3. Recent Q-wave myocardial infarction or revascularization procedure ( = 3 months).

4. Standard contra-indications to MRI.

5. Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast).

6. Estimated Glomerular Filtration Rate (eGFR) = 45 ml/min/m2.

7. Patient is pregnant.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

Procedure:
• Image guided delivery of cardiac pacing leads.
Patients will be blindly randomized to image guided delivery of pacing leads during cardiac resynchronization therapy device implantation (study arm).
• Standard delivery of cardiac pacing leads.
Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)	Cardiac Resynchronization Therapy (CRT) response will be defined as a change in the Left Ventricular Ejection Fraction measured at 6 months post CRT device implant by MUGA ( cardiac wall motion study) scan.	6 months	No
Secondary	To determine if image guided lead delivery will result in a higher rate of lead delivery to optimal myocardial segments.	Cardiac CT scan will be performed at 3 months post CRT device implantation to determine secondary outcome listed above. The left ventricular (LV) lead site will be assessed for targets of dysychronous myocardium and proximity to scar tissue. The right ventricular (RV) lead will be assessed for proximity to scar tissue.	3 months	No