Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Syncope Clinical Trial

— PRESS  

Official title:

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463358
• Other study ID #: GDT-20040601-PRESS-1
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Est. completion date: May 2011

Study information

• Verified date: March 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bifascicular Block
• Syncope

Intervention

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
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Italy, 

Outcome

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