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.
ID
Bron
Verkorte titel
Aandoening
Chronic heart failure with a reduced ejection fraction and dyssynchrony
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Differences in % of patients with succesfull LV lead location between intervention and control group.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Real-time cardiac Magnetic Resonance-guided lead implantation by CARTBox.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8666 |
| CCMO | NL73416.041.20 |
| OMON | NL-OMON54061 |