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ID
Source
Brief title
Health condition
Chronic heart failure with a reduced ejection fraction and dyssynchrony
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in % of patients with succesfull LV lead location between intervention and control group.
Secondary outcome
Secondary Outcomes:
- Change in LV end-systolic volume, and proportion of volumetric response.
- Change in EQ-5D-5L, a quality of life questionnaire.
- Change in Kansas City Cardiomyopathy Questionnaire, a quality of life questionnaire.
- Change in CRT response score, a hierarchical clinical endpoint combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up.
- Health Technology Assessment.
Other Outcomes:
- Difference in total implantation procedure time.
- Difference in total fluoroscopy time during procedure.
- Difference in total contrast dose used during procedure.
- Difference in change in QRS duration.
- Difference in change in QRSarea.
- Difference in Q-LV sense.
- Difference in pacing threshold.
- Difference in % of patients with disappearance of apical rocking.
Background 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 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 fluroscopy in a blinded, multicenter, randomized controlled trial.
Study objective
Primary Outcome: Targeted LV lead delivery results in a higher proportion of in-target pacing when compared to the control group.
Secondary Outcomes: Targeted LV lead delivery results in more clinical benefit when compared to the control group.
Study design
Timepoint 1 (pre-implantation): ECG, NYHA, CMR and echocardiography
Timepoint 2 (during implantation): Guided or conventional CRT implantation
Timepoint 3 (follow-up at 6 months): ECG, NYHA, echocardiography
Timepoint 4 (one and two years): long-term clinical outcome and quality of life
Intervention
Real-time cardiac Magnetic Resonance-guided lead implantation by CARTBox.
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
Contraindications for implantation of a CRT device;
- Age <18 years or incapacitated adult;
- 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.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8666 |
| CCMO | NL73416.041.20 |
| OMON | NL-OMON54061 |