NCT03961399: CRUSTY

Study to Evaluate the Superior Efficacy of Cardiac Resynchronization (SyncAVTM) Using the SyncAVTM Algorithm

Completed NA Last updated 4 October 2023

What this trial tests

NA trial testing Abbott Medical® CRT device with SyncAVTM stimulation function in Heart Failure in 56 participants. Completed in 27 October 2021.

Timeline

18 December 2018

Primary endpoint
27 October 2021

27 October 2021

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	56
Start date	18 December 2018
Primary completion	27 October 2021
Estimated completion	27 October 2021
Sites	15 locations across Spain

Drugs / interventions tested

• Abbott Medical® CRT device with SyncAVTM stimulation function
• Abbott Medical® CRT device with biventricular stimulation (BiV)

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart Failure (HF) is a cardiovascular disease secondary to a structural and / or functional alteration of the heart that prevents its correct function.

The Cardiac resynchronization therapy (CRT) aims to restore atrioventricular, inter and intraventricular synchrony in patients with systolic HF and wide depolarization of the ventricles (QRS). Although CRT has been shown to be effective, the rate of non-responders is high (30-50%).

One of the proposed reasons for the lack of response to the CRT is the lack of intrinsic conduction, since most of the time CRT is administered using biventricular stimulation (BiV). One of the limitations to achieve ventricular fusion are the dynamic physiological variations of the auriculo-ventricular (AV) interval.

The SyncAVTM algorithm is a new dynamic algorithm that manages to adjust the AV intervals outside the clinic.

The design of the present clinical study is post-marketing, prospective, multicenter, randomized and blind for the patient and the central echocardiography laboratory.

The objective of this study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with conventional BiV stimulation in the population for which its use is foreseen.

The data will be collected in at least the Selection / Baseline Visit and in the Visit of Follow-up at 6 Months.

The study population are subjects to whom an Abbott Medical CRT has been implanted with SyncAVTM® Stimulation function that go to the participating sites in the study.

The main objective of the study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with BiV stimulation conventional in terms of the rate of responders.

The main endpoint is the determination of significant differences between conventional BiV stimulation and ventricular stimulation with fusion using the SyncAVTM algorithm in terms of the percentage of patients responding to CRT therapy with echocardiogram.

The duration of the clinical study is estimated at 24 months with a recruitment period of 18 months and a patient follow-up of 6 months. The number of subjects that is planned to be recruited is 176. The inclusion will be competitive and there is no inclusion number determined per site.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Optimization of Chronic Cardiac Resynchronization Therapy Using Fusion Pacing Algorithm Improves Echocardiographic Response.
   AlTurki A, Lima PY, Bernier ML, Garcia D, et al · · 2020 · cited 11× · PMID 32190827 · DOI 10.1016/j.cjco.2019.12.005