Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient has a LVEF ≤ 35%

• Patient has a LVEDD ≥ 2.7cm/m² or LVEDD ≥ 50mm (m) and ≥45mm (f)

• Patient has been in a stable medical condition for ≥ 1 month prior inclusion

• Patient underwent complete revascularization in case of ischemia

• Patients is able to understand and willing to provide a written informed consent

• Patient is 18 years or older

Locations
Other Locations
Belgium
University Hospital Antwerp
RECRUITING
Antwerp
ZNA Middelheim
RECRUITING
Antwerp
AZ Sint-Jan Brugge
RECRUITING
Bruges
AZ Maria Middelares
RECRUITING
Ghent
Ghent University Hospital
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
AZ Damiaan
RECRUITING
Ostend
AZ Delta
RECRUITING
Roeselare
Brazil
Dante Pazzanese Institute of Cardiology
RECRUITING
São Paulo
France
CHRU Brest
RECRUITING
Brest
Groupements des hôpitaux de l'institut catholique de Lille
RECRUITING
Lille
CHU Rennes - Pontchaillou Hospital
RECRUITING
Rennes
Germany
St. Vinzenz-Hospital
RECRUITING
Cologne
Universitätsmedizin Rostock
RECRUITING
Rostock
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Hungary
Semmelweis University Heart Center
RECRUITING
Budapest
Latvia
Paul Stradins Clinical University hospital
RECRUITING
Riga
Poland
Poznan University of Medical Sciences
RECRUITING
Poznan
Klinika Wad Wrodzonych Serca
RECRUITING
Warsaw
Silesian Center for Heart Diseases
RECRUITING
Zabrze
Portugal
CHU de São João
RECRUITING
Porto
Romania
Heart Institute Nicolae Stancioiu
RECRUITING
Cluj-napoca
Spain
Hospital Clínico de Barcelona
RECRUITING
Barcelona
Switzerland
Universitätsspital Zürich
RECRUITING
Zurich
Contact Information
Primary
Jens-Uwe Voigt, MD, PhD
jens-uwe.voigt@uzleuven.be
+32 16 34 90 16
Backup
Alexis Puvrez, MD
alexis.puvrez@kuleuven.be
+32 16 34 58 43
Time Frame
Start Date: 2020-12-10
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 700
Treatments
Active_comparator: Treatment recommendation based on guidelines
Treatment of the patient assigned to this arm will be based on the current guidelines for CRT implantation, as issued by the European Society of Cardiology. All patients will receive CRT implantation, with bi-ventricular pacing ON.
Experimental: Treatment recommendation based on mechanical dyssynchrony
Treatment of the patients assigned to this arm will be based on the presence of mechanical dyssynchrony. All patients will receive CRT implantation. Bi-ventricular pacing will be either turned ON or OFF, based on respectively the presence or absence of mechanical dyssynchrony.
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov

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