Pacing in Cardiac Magnetic Resonance Imaging: a CRT trial

Completed

• Conditions: chronic heart failure; 10019280

• Registration Number: NL-OMON47190
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Patients need to fulfil the 2013 guideline of the European Society of Cardiology criteria for cardiac pacing and cardiac resynchronisation therapy. In order to participate in this study, a subject must meet all of the following criteria:
- Chronic heart failure
- New York Heart Association (NYHA) functional class II, III or ambulant IV
- QRS duration * 120ms
- Left bundle branch block
- Optimal pharmacological therapy
- LV ejection fraction * 35%
- Sinus rhythm

Exclusion Criteria

The exclusion criteria applying for this study are:
- Age <18 or incapacitated adult
- Significant rhythm abnormalities (irregularity by atrial fibrillation or frequent extrasystole)
- Artificial heart valves
- Pacemaker dependency

The exclusion criteria regarding CMR are:
- Lactation
- Documented allergic reaction to gadolinium
- Subjects with severely impaired renal function (GFR < 30 ml/min/1.73m2)
- Impossibility to undergo a MRI scan (determined by using the standard contraindications
for MR imaging as used for clinical purposes)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is CMR cine image quality, quantified by grading 17 LV<br /><br>segments on a 5-point grading scale (grade 1 is excellent and 5<br /><br>non-diagnostic). Image quality will be compared post- versus pre-implantation.<br /><br>Quantitative LV functional and volumetric CMR parameters will be determined<br /><br>during intrinsic rhythm and during biventricular stimulation, this will be<br /><br>compared to pre-implantation CMR measurements (intrinsic rhythm) and invasive<br /><br>measurements (biventricular stimulation). </p><br>