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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.
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:
Sample: 100 patients
Population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDI30 | Other | Control group based only on backup pacing with lower rate 30 ppm |
|
| DDD60 | Active Comparator | Treatment arm based on full pacing support (60 Lower Rate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) | Device | pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin. | 2 years | |
| Atrial Fibrillation | patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Santini, MD,FESC,FACC | Ospedale San Filippo Neri, Roma, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Santa Maria Annunziata | Bagno a Ripoli | Italy | ||||
| Azienda Ospedaliera S. Sebastiano |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24336948 | Derived | 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. | |
| 23390123 |
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| ID | Title | Description |
|---|---|---|
| FG000 | DDI30 | Control group based only on backup pacing with lower rate 30 ppm 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) | Device | 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. |
|
|
| 2 years |
| 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 |
| Derived |
| Santini 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. |
| DDD60 |
Treatment arm based on full pacing support (60 Lower Rate) 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DDI30 | Control group based only on backup pacing with lower rate 30 ppm 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. |
| BG001 | DDD60 | Treatment arm based on full pacing support (60 Lower Rate) 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin. | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Atrial Fibrillation | patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period | Posted | Count of Participants | Participants | 2 years |
|
|
2 years
number of subjects with serious and non-serious adverse events of cardiac and non-cardiac origin, with identification of organ cause. Method for systematic assessment: regular investigator assessment at follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DDI30 | Control group based only on backup pacing with lower rate 30 ppm 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. | 2 | 49 | 33 | 49 | 22 | 49 |
| EG001 | DDD60 | Treatment arm based on full pacing support (60 Lower Rate) 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 | 2 | 52 | 23 | 52 | 20 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| atrio-ventricular block | Cardiac disorders | Systematic Assessment |
| ||
| symptomatic bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| symptomatic atrial arrhyhtmias | Cardiac disorders | Systematic Assessment | serious: requiring hospitalizations |
| |
| ventricular arrhyhtmias | Cardiac disorders | Systematic Assessment |
| ||
| Heart Failure exhacerbation | Cardiac disorders | Systematic Assessment |
| ||
| Miocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| intervention for coronary artery disease | Cardiac disorders | Systematic Assessment | Coronary artery Bypass Graft or Percutaneous angioplasty |
| |
| Stroke | Cardiac disorders | Systematic Assessment |
| ||
| transient ischemic attack | Cardiac disorders | Systematic Assessment |
| ||
| peripheral vascular disease | Vascular disorders | Systematic Assessment |
| ||
| Vascular encephalopathy | Vascular disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease (COPD) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Loss of pacemaker capture | Product Issues | Systematic Assessment | requiring invasive system revision |
| |
| Pacing lead dislodgment | Product Issues | Systematic Assessment | requiring invasive system revision |
| |
| Pacemaker system infection | Product Issues | Systematic Assessment |
| ||
| Gastrointestinal disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Musculoskeletal trauma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Renal disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Fever/virus | General disorders | Systematic Assessment |
| ||
| Tumor | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | Systematic Assessment |
| ||
| symptomatic Atrial Arrhythmias | Cardiac disorders | Systematic Assessment | non-serious: not requiring hospitalisation |
| |
| Heart Failure | Cardiac disorders | Systematic Assessment | non-serious: treated with variation to medical therapy |
| |
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| pacemaker signal oversensing/undersensing | Product Issues | Systematic Assessment | non serious: resolved with pacemaker reprogramming |
| |
| pacemaker: rise in pacing threshold | Product Issues | Systematic Assessment | non serious: resolved with pacemaker reprogramming |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Massimo Santini MD FESC FACC | Casa di Cura san Pio XI | +390666494491 | m.santini@rmnet.it |
| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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