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Image Supported Lead Placement in CRT

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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.

Study details

Heart Failure

NCT05053568

UMC Utrecht

25 January 2024

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