MedTrace Logo

Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

NCT01528657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2015-10-22

No results posted yet for this study

Summary

The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.

Conditions

  • Sick Sinus Syndrome

Interventions

OTHER

Ventricular Pace Suppression (Vps)

Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.

OTHER

Intrinsic rhythm support (IRSplus)

All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Alessandro Capucci · A.O.U. Ospedali Riuniti, Ancona

  • Valeria Calvi · A.O.U. Policlinico-Vittorio Emanuele, Catania

  • Marco Brieda · A.O. Santa Maria degli Angeli, Pordenone

  • Ennio Pisanò · P.O. Vito Fazzi, Lecce

  • Vittorio Giudici · Ospedale Bolognini, Seriate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT01528657 on ClinicalTrials.gov