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Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

NCT01463358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-04-19

Study results available
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Summary

Study Objective

The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.

Conditions

  • Bifascicular Block
  • Syncope

Interventions

DEVICE

DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block

DEVICE

DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Massimo Santini, MD,FESC,FACC · Ospedale San Filippo Neri, Roma, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • Italy

Study Locations

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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 NCT01463358 on ClinicalTrials.gov