Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
PRESS
1 other identifier
interventional
101
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2005
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedResults Posted
Study results publicly available
April 19, 2021
CompletedApril 19, 2021
March 1, 2021
5.9 years
June 27, 2011
January 4, 2021
March 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.
2 years
Atrial Fibrillation
2 years
Study Arms (2)
DDI30
OTHERControl group based only on backup pacing with lower rate 30 ppm
DDD60
ACTIVE COMPARATORTreatment arm based on full pacing support (60 Lower Rate)
Interventions
pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block
Eligibility Criteria
You may qualify if:
- Evidence of Bifascicular block
- At least one episode of syncope during last 6 months from the enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
Florence, 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, Italy
Related Publications (2)
Brignole M, Donateo P, Tomaino M, Massa R, Iori M, Beiras X, Moya A, Kus T, Deharo JC, Giuli S, Gentili A, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Benefit of pacemaker therapy in patients with presumed neurally mediated syncope and documented asystole is greater when tilt test is negative: an analysis from the third International Study on Syncope of Uncertain Etiology (ISSUE-3). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):10-6. doi: 10.1161/CIRCEP.113.001103. Epub 2013 Dec 12.
PMID: 24336948DERIVEDSantini M, Castro A, Giada F, Ricci R, Inama G, Gaggioli G, Calo L, Orazi S, Viscusi M, Chiodi L, Bartoletti A, Foglia-Manzillo G, Ammirati F, Loricchio ML, Pedrinazzi C, Turreni F, Gasparini G, Accardi F, Raciti G, Raviele A. Prevention of syncope through permanent cardiac pacing in patients with bifascicular block and syncope of unexplained origin: the PRESS study. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):101-7. doi: 10.1161/CIRCEP.112.975102. Epub 2013 Feb 6.
PMID: 23390123DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Massimo Santini MD FESC FACC
- Organization
- Casa di Cura san Pio XI
Study Officials
- PRINCIPAL INVESTIGATOR
Massimo Santini, MD,FESC,FACC
Ospedale San Filippo Neri, Roma, Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2011
First Posted
November 1, 2011
Study Start
March 1, 2005
Primary Completion
February 1, 2011
Study Completion
May 1, 2011
Last Updated
April 19, 2021
Results First Posted
April 19, 2021
Record last verified: 2021-03