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Post-market Prospective, Multicenter, Randomized and Single-blinded Clinical Investigation to Evaluate Whether Cardiac Re-Synchronization Therapy (CRT) Using Automatic Continuous Atrioventricular (AV) Delay Optimization is Superior to CRT With Conventional Biventricular Stimulation (BiV).

NCT06044597 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2023-09-21

No results posted yet for this study

Summary

The goal of this randomized, multicenter prospective study is to demonstrate that the activation of biventricular pacing with fusion and AV optimization feature will increase the rate of CRT responders in terms of LV reverse remodeling, compared with conventional biventricular pacing.

Conditions

Interventions

DEVICE

SyncAV function on

CRT-D with SyncAV plus activated

Sponsors & Collaborators

  • Antonio Rapacciuolo

    lead OTHER

Principal Investigators

  • Jaume Francisco Pascual, Dr · Hospital Vall d'Hebron

  • Nuria Rivas Gandara, Dr · Hospital Vall d'Hebron

  • Angelo Auricchio, Prof · Istituto Cardiocentro Ticino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-04-30
Completion
2026-10-30

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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 NCT06044597 on ClinicalTrials.gov