NCT05053568Active, not recruiting
Image Supported Lead Placement in CRT
Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 27 Aug 2021
- Start date
- 8 Feb 2021
- Primary completion date
- 1 Oct 2023
- Lead sponsor
- UMC Utrecht
- Diseases
- Heart failure
- NCT number
- NCT05053568
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 8 Feb 2021 to the primary completion date, 1 Oct 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Documented allergic reaction to gadolinium;
Lab values
- Subjects with impaired renal function (severe renal insufficiency, GFR \< 30 ml/min/1.73m2);
Other
- Pregnancy or lactation;
- Atrial fibrillation or atrial fibrillation during MRI
- Impossibility to undergo an MRI scan;
- Participation in another clinical study that prohibits any procedures other than standard.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| St. Antonius Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Isala Zwolle Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.