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

NCT03961399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-10-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Abbott Medical® CRT device with SyncAVTM stimulation function

patients with Abbott Medical® CRT device will be randomized and SyncAVTM stimulation will be activated.

DEVICE

Abbott Medical® CRT device with biventricular stimulation (BiV)

patients with Abbott Medical® CRT device will be randomized and biventricular (BiV) stimulation will be activated.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Jaume Francisco Pascual, MD · Institut of research Vall d'hebron Hospital (VHIR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2021-10-27
Completion
2021-10-27

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961399 on ClinicalTrials.gov