Bifascicular BlockPRESSNCT01463358
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
A study testing DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) in people with Bifascicular Block and Syncope, run by Boston Scientific Corporation at 12 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bifascicular Block, Syncope
- What is being tested?
- DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 12 sitesItaly
- Study dates
- Mar 2005to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of Bifascicular block
- At least one episode of syncope during last 6 months from the enrollment
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Ospedale Santa Maria Annunziata
Bagno a Ripoli
Azienda Ospedaliera S. Sebastiano
Caserta
Ospedale Valduce
Como
Azienda Ospedaliera Osp. Maggiore
Crema
Nuovo Ospedale S. Giovanni di Dio
Florence
Ospedale Villa Scassi
Genova
Ospedale Umberto I
Mestre
Ospedale GB Grassi
Ostia - Roma
Ospedale Civile G. De Lellis
Rieti
Azienda Ospedaliera S. Filippo Neri
Roma
Ospedale Sandro Pertini
Roma
Policlinico Casilino
Roma
About this study
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.
Read the 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
- Conditions
- Bifascicular Block, Syncope
- Being tested
- DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
- Keywords
- Syncope, Bifascicular block, Bradycardia pacing
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)Device
Also called 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)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| DDI30 | Other | Control group based only on backup pacing with lower rate 30 ppm Receives: Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) |
| DDD60 | Active comparator | Treatment arm based on full pacing support (60 Lower Rate) Receives: Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.
Measured: 2 years
Atrial Fibrillation
patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startMar 2005
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bifascicular BlockStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Santini, MD,FESC,FACC, Principal investigator, Ospedale San Filippo Neri, Roma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463358
- Sponsor's protocol ID
- GDT-20040601-PRESS-1
- Acronym
- PRESS
- Status last verified
- Mar 2021
- First submitted
- 27 Jun 2011
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24336948Santini 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.
PubMed 23390123
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
- ClinicalTrials.gov ID
- NCT01463358
- Acronym / sponsor ID
- PRESS / GDT-20040601-PRESS-1
- Conditions
- Bifascicular Block, Syncope
- Keywords
- Syncope, Bifascicular block, Bradycardia pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDI30 | Other | Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)Control group based only on backup pacing with lower rate 30 ppm |
| DDD60 | Active comparator | Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)Treatment arm based on full pacing support (60 Lower Rate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Evidence of Bifascicular block
- At least one episode of syncope during last 6 months from the enrollment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)Also: 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 |
| DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)Also: 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. | Device | DDI30 |
Primary outcome
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 secondary outcomes
Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.
Time frame: 2 years
Atrial Fibrillation
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24336948Brignole 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.
- Derived from this study: PubMed 23390123Santini 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Santini, MD,FESC,FACC principal investigator
Ospedale San Filippo Neri, Roma, Italy
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) in people with Bifascicular Block and Syncope, run by Boston Scientific Corporation at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01463358, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.