Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- UMC Utrecht
- Enrollment
- 130
- Locations
- 7
- Primary Endpoint
- Differences in % of patients with succesfull LV lead location
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.
Investigators
M. Meine
Principal Investigator (MD, PhD)
UMC Utrecht
Eligibility Criteria
Inclusion Criteria
- •Heart failure with LV ejection fraction ≤ 35%;
- •New York Heart Association class II, III, or IV (ambulatory);
- •Optimal medical treatment that is tolerable;
- •Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms.
Exclusion Criteria
- •Pregnancy or lactation;
- •Subjects with impaired renal function (severe renal insufficiency, GFR \< 30 ml/min/1.73m2);
- •Atrial fibrillation or atrial fibrillation during MRI
- •Documented allergic reaction to gadolinium;
- •Impossibility to undergo an MRI scan;
- •Participation in another clinical study that prohibits any procedures other than standard.
Outcomes
Primary Outcomes
Differences in % of patients with succesfull LV lead location
Time Frame: Direct post-CRT
Lead location, defined as being within, adjacent, or remote from the pre-defined target.
Secondary Outcomes
- Change in Kansas City Cardiomyopathy Questionnaire(6, 12 and 24 months)
- Change in EQ-5D-5L(6, 12 and 24 months)
- Change in reverse remodelling and volumetric response(6 months)
- Health Technology Assessment(24 months)
- Change in CRT response score(12 months)