Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block (PRESS)

March 23, 2021 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary endpoint

First occurrence of a composite of Syncope of any origin OR Presyncopal episode with documented cardioinhibitory origin OR Atrioventricular block of any degree; all associated with patient symptoms

Design:

  • Randomized, prospective, single blinded, two parallel arms
  • Treatment group : DDD60 - programmed in DDD mode / 60 lower limit
  • Control Group: DDI30 - programmed in DDI mode / 30 lower limit
  • Randomization type: block randomization: Block size: 4, allocation ratio 1:1

Sample: 100 patients

Population

  • Patients with bifascicular block with at least one syncopal episode within the last 6 months preceding enrollment.
  • Patients should be negative to a series of pre-enrollment screening in order to exclude:
  • Brady-tachy syndrome, vasovagal syncope or carotid sinus syndrome, atrial fibrillation, inducible AV block
  • Ejection fraction >=40%
  • Mean nocturnal heart rate >=35 bpm

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bagno a Ripoli, Italy
        • Ospedale Santa Maria Annunziata
      • Caserta, Italy
        • Azienda Ospedaliera S. Sebastiano
      • Como, Italy
        • Ospedale Valduce
      • Crema, Italy
        • Azienda Ospedaliera Osp. Maggiore
      • Firenze, Italy
        • Nuovo Ospedale S. Giovanni di Dio
      • Genova, Italy
        • Ospedale Villa Scassi
      • Mestre, Italy
        • Ospedale Umberto I
      • Ostia - Roma, Italy
        • Ospedale GB Grassi
      • Rieti, Italy
        • Ospedale Civile G. De Lellis
      • Roma, Italy
        • Ospedale Sandro Pertini
      • Roma, Italy
        • Policlinico Casilino
      • Roma, Italy
        • Azienda Ospedaliera S. Filippo Neri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Evidence of Bifascicular block
  • At least one episode of syncope during last 6 months from the enrollment

Exclusion Criteria:

  • Patients with Brady-tachy syndrome that needs of pacemaker to prevent the symptomatic bradycardia o symptomatic tachycardia arrhythmia
  • Patients with vasovagal syndrome by positive TTT or carotid sinus syndrome
  • Patients with Chronic Atrial Fibrillation
  • Patients with Atrial Ventricular Block induces at EPS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DDI30
Control group based only on backup pacing with lower rate 30 ppm
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
Other Names:
  • INSIGNIA® pacing systems Guidant (Boston Scientific)
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.
Other Names:
  • INSIGNIA® pacing systems Guidant (Boston Scientific)
Active Comparator: DDD60
Treatment arm based on full pacing support (60 Lower Rate)
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
Other Names:
  • INSIGNIA® pacing systems Guidant (Boston Scientific)
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.
Other Names:
  • INSIGNIA® pacing systems Guidant (Boston Scientific)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined Endpoint Defined as First Occurrence Among the Following Events 1)Syncope Episode of Any Origin; 2)Presyncopal Episode With Documented Cardioinhibitory Origin 3) Atrioventricular Block of Any Degree Associated With Patient Symptoms
Time Frame: 2 years
Number of participants experiencing syncope episodes, symptomatic pre-syncopal episodes associated with a device intervention (ventricular pacing) and symptomatic episodes associated with documentation of intermittent or permanent atrio-ventricular block
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.
Time Frame: 2 years
2 years
Atrial Fibrillation
Time Frame: 2 years
patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Massimo Santini, MD,FESC,FACC, Ospedale San Filippo Neri, Roma, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

October 28, 2011

First Posted (Estimate)

November 1, 2011

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDT-20040601-PRESS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Syncope

Clinical Trials on DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe