Trial Outcomes & Findings for Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block (NCT NCT01463358)

Last Updated: 2021-04-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

2 years

Results posted on

2021-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	49	52
Overall Study COMPLETED	46	47
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DDI30 n=49 Participants 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.	DDD60 n=52 Participants 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	Total n=101 Participants Total of all reporting groups
Age, Continuous	78 years STANDARD_DEVIATION 8 • n=5 Participants	77 years STANDARD_DEVIATION 8 • n=7 Participants	77 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	35 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment Italy	49 participants n=5 Participants	52 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	DDI30 n=49 Participants 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.	DDD60 n=52 Participants 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
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	16 Participants	7 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	DDI30 n=49 Participants 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.	DDD60 n=52 Participants 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
Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.	22 Participants	13 Participants

SECONDARY outcome

Timeframe: 2 years

patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period

Outcome measures

Outcome measures
Measure	DDI30 n=49 Participants 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.	DDD60 n=52 Participants 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
Atrial Fibrillation	9 Participants	18 Participants

Adverse Events

DDI30

Serious events: 33 serious events

Other events: 22 other events

Deaths: 2 deaths

DDD60

Serious events: 23 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	DDI30 n=49 participants at risk 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.	DDD60 n=52 participants at risk 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
Cardiac disorders Dizziness	30.6% 15/49 • Number of events 23 • 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.	15.4% 8/52 • Number of events 8 • 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.
Cardiac disorders symptomatic Atrial Arrhythmias	0.00% 0/49 • 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.	3.8% 2/52 • Number of events 2 • 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.
Cardiac disorders Heart Failure	10.2% 5/49 • Number of events 6 • 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.	7.7% 4/52 • Number of events 4 • 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.
Vascular disorders Hypertension	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 1 • 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.
Product Issues pacemaker signal oversensing/undersensing	12.2% 6/49 • Number of events 7 • 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.	17.3% 9/52 • Number of events 14 • 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.
Product Issues pacemaker: rise in pacing threshold	4.1% 2/49 • Number of events 2 • 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.	5.8% 3/52 • Number of events 3 • 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.

Additional Information

Massimo Santini MD FESC FACC

Casa di Cura san Pio XI

Phone: +390666494491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DDI30 n=49 participants at risk 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.	DDD60 n=52 participants at risk 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
Cardiac disorders Syncope	14.3% 7/49 • Number of events 9 • 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.	13.5% 7/52 • Number of events 10 • 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.
Cardiac disorders atrio-ventricular block	16.3% 8/49 • Number of events 9 • 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.	3.8% 2/52 • Number of events 2 • 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.
Cardiac disorders symptomatic bradycardia	18.4% 9/49 • Number of events 9 • 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.	1.9% 1/52 • Number of events 1 • 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.
Cardiac disorders symptomatic atrial arrhyhtmias	0.00% 0/49 • 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.	3.8% 2/52 • Number of events 3 • 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.
Cardiac disorders ventricular arrhyhtmias	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 1 • 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.
Cardiac disorders Heart Failure exhacerbation	4.1% 2/49 • Number of events 2 • 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.	9.6% 5/52 • Number of events 5 • 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.
Cardiac disorders Miocardial Infarction	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 1 • 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.
Cardiac disorders intervention for coronary artery disease	4.1% 2/49 • Number of events 2 • 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.	0.00% 0/52 • 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.
Cardiac disorders Stroke	2.0% 1/49 • Number of events 1 • 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.	0.00% 0/52 • 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.
Cardiac disorders transient ischemic attack	2.0% 1/49 • Number of events 1 • 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.	0.00% 0/52 • 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.
Vascular disorders peripheral vascular disease	2.0% 1/49 • Number of events 1 • 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.	0.00% 0/52 • 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.
Vascular disorders Vascular encephalopathy	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease (COPD)	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 3 • 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.
Product Issues Loss of pacemaker capture	6.1% 3/49 • Number of events 3 • 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.	0.00% 0/52 • 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.
Product Issues Pacing lead dislodgment	2.0% 1/49 • Number of events 1 • 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.	1.9% 1/52 • Number of events 1 • 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.
Product Issues Pacemaker system infection	4.1% 2/49 • Number of events 2 • 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.	1.9% 1/52 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal disease	0.00% 0/49 • 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.	3.8% 2/52 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal trauma	10.2% 5/49 • Number of events 5 • 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.	3.8% 2/52 • Number of events 2 • 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.
Renal and urinary disorders Renal disease	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 1 • 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.
Renal and urinary disorders Urinary disease	2.0% 1/49 • Number of events 1 • 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.	1.9% 1/52 • Number of events 1 • 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.
General disorders Fever/virus	0.00% 0/49 • 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.	1.9% 1/52 • Number of events 1 • 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.
General disorders Tumor	2.0% 1/49 • Number of events 1 • 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.	1.9% 1/52 • Number of events 1 • 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.