Trial Outcomes & Findings for Electrophysiologically Guided PAcing Site Selection Study (NCT NCT00239226)
NCT ID: NCT00239226
Last Updated: 2013-11-25
Results Overview
Persistent Atrial Fibrillation (AF) incidence
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
1 year
Results posted on
2013-11-25
Participant Flow
Enrollment: november 2005 - may 2008 Sites:Ospedale P. Cosma Camposampiero-Ospedale Civile ULSS 13 Mirano-Ospdale Civile,Como-Ospedale Cisanello,Pisa-CRN,Pisa-Ospedale civile, Livorno-Ospedale Molinette, Torino-Presidi Ospedalieri Riuniti,Borgomanero-Ospedale San Pietro Igneo, Fucecchio-Azienda Ospedaliera di Desenzano del Garda Desenzano
Participant milestones
| Measure |
IAS Pacing Study Group
Patients with with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
|
IAS Pacing Control Group
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
|
RAA Pacing Study Group
Patients with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
|
RAA Pacing Control Group
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
18
|
37
|
17
|
|
Overall Study
COMPLETED
|
29
|
18
|
36
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
IAS Pacing Study Group
Patients with with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
|
IAS Pacing Control Group
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
|
RAA Pacing Study Group
Patients with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
|
RAA Pacing Control Group
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
|
|---|---|---|---|---|
|
Overall Study
permAF during stabilization period
|
0
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Electrophysiologically Guided PAcing Site Selection Study
Baseline characteristics by cohort
| Measure |
IAS Pacing Study Group
n=30 Participants
Patients with with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
|
IAS Pacing Control Group
n=18 Participants
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
|
RAA Pacing Study Group
n=37 Participants
Patients with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
|
RAA Pacing Control Group
n=17 Participants
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
92 Participants
n=36 Participants
|
|
Age Continuous
|
75 years
STANDARD_DEVIATION 7 • n=93 Participants
|
79 years
STANDARD_DEVIATION 6 • n=4 Participants
|
75 years
STANDARD_DEVIATION 7 • n=27 Participants
|
81 years
STANDARD_DEVIATION 5 • n=483 Participants
|
77 years
STANDARD_DEVIATION 7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
58 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Region of Enrollment
Italy
|
30 participants
n=93 Participants
|
18 participants
n=4 Participants
|
37 participants
n=27 Participants
|
17 participants
n=483 Participants
|
102 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 97 pts completed the study after a mean fu period of 15±7 months.
Persistent Atrial Fibrillation (AF) incidence
Outcome measures
| Measure |
IAS Pacing Study Group
n=29 Participants
Patients with with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
|
IAS Pacing Control Group
n=18 Participants
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
|
RAA Pacing Study Group
n=36 Participants
Patients with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
|
RAA Pacing Control Group
n=14 Participants
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
|
|---|---|---|---|---|
|
Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group
|
2 Number of patients with persistent AF
|
2 Number of patients with persistent AF
|
9 Number of patients with persistent AF
|
2 Number of patients with persistent AF
|
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: January 2009Outcome measures
Outcome data not reported
Adverse Events
IAS Pacing Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IAS Pacing Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
RAA Pacing Study Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
RAA Pacing Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IAS Pacing Study Group
n=29 participants at risk
Patients with with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
|
IAS Pacing Control Group
n=18 participants at risk
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
|
RAA Pacing Study Group
n=36 participants at risk
Patients with severe conduction delay (Delta CTos \>50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
|
RAA Pacing Control Group
n=14 participants at risk
Patients without severe conduction delay (Delta CTos \<50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
|
|---|---|---|---|---|
|
Cardiac disorders
Hospitalization for HF
|
0.00%
0/29
|
5.6%
1/18 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
0.00%
0/14
|
Other adverse events
Adverse event data not reported
Additional Information
Giorgio Corbucci - Sr Principal Scientist
Medtronic BRC - Medtronic Italia SpA
Phone: +39 02 241371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee INVESTIGATOR may publish/present the results of the work. However, INVESTIGATOR shall provide copies of any abstracts, or manuscripts to the sponsor for review at least 30 (thirty) days prior to submittal for publication or presentation. The sponsor shall limit its review to a determination of whether Confidential Information is disclosed and to check for technical correctness. Sponsor shall not attempt to censor or in any way interfere with INVESTIGATOR's presentation or conclusions.
- Publication restrictions are in place
Restriction type: OTHER