Trial Outcomes & Findings for Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker (NCT NCT00916344)
NCT ID: NCT00916344
Last Updated: 2011-10-07
Results Overview
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
1 month follow-up completed
Results posted on
2011-10-07
Participant Flow
In this study the data of n = 175 patients from 34 clinical sites in Austria, Denmark, France, Germany, Spain, Sweden and United Kingdom are included. The period of investigation covered was between June 04, 2009 (day of first implant) and February 26, 2010 (day of last follow-up).
Participant milestones
| Measure |
Pacemaker Therapy
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
Overall Study
STARTED
|
175
|
|
Overall Study
COMPLETED
|
167
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Pacemaker Therapy
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
ICD upgrade
|
1
|
|
Overall Study
Drop-out
|
5
|
Baseline Characteristics
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
Baseline characteristics by cohort
| Measure |
Pacemaker Therapy
n=175 Participants
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
Age Continuous
|
74 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Age, Customized
Between 34 and 93 years
|
175 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
19 participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
93 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month follow-up completedPopulation: At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis).
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
Outcome measures
| Measure |
Pacemaker Therapy
n=93 (dual chamber pacemakers only at 1 mFU)
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
|
-0.01 Volt
Interval -0.03 to 0.02
|
SECONDARY outcome
Timeframe: 1- and 3- month follow-up completedComplication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients)
Outcome measures
| Measure |
Pacemaker Therapy
n=175 Participants
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
Complication Free Rate
|
99 Percentage complication free patients
Interval 96.0 to 100.0
|
Adverse Events
Pacemaker Therapy
Serious events: 52 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pacemaker Therapy
n=175 participants at risk
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
Cardiac disorders
Atrial fibrillation / flutter related
|
1.7%
3/175 • Number of events 3
|
|
Surgical and medical procedures
ablation
|
0.57%
1/175 • Number of events 1
|
|
Blood and lymphatic system disorders
acute circulation insufficiency
|
0.57%
1/175 • Number of events 1
|
|
Surgical and medical procedures
bypass operation
|
1.1%
2/175 • Number of events 2
|
|
Cardiac disorders
cardiac decompensation
|
2.9%
5/175 • Number of events 7
|
|
Surgical and medical procedures
cardiogenic shock during implantation
|
0.57%
1/175 • Number of events 1
|
|
Cardiac disorders
chest pain
|
1.7%
3/175 • Number of events 3
|
|
Surgical and medical procedures
coronary angiography
|
1.7%
3/175 • Number of events 3
|
|
Cardiac disorders
coronary artery disease related
|
1.1%
2/175 • Number of events 2
|
|
Renal and urinary disorders
cystitis
|
0.57%
1/175 • Number of events 1
|
|
Nervous system disorders
dementia
|
0.57%
1/175 • Number of events 1
|
|
Endocrine disorders
diabetes related
|
0.57%
1/175 • Number of events 3
|
|
Renal and urinary disorders
dialysis related
|
0.57%
1/175 • Number of events 1
|
|
Infections and infestations
fever and infection
|
0.57%
1/175 • Number of events 1
|
|
Surgical and medical procedures
foot amputation due to endocrine disorder
|
0.57%
1/175 • Number of events 1
|
|
Cardiac disorders
hypotension
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
intestinal disease
|
1.7%
3/175 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
joint and bone related
|
1.1%
2/175 • Number of events 2
|
|
Surgical and medical procedures
lead dislocation
|
5.7%
10/175 • Number of events 11
|
|
Social circumstances
lifestyle modification
|
0.57%
1/175 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
lung related hospitalisation
|
1.7%
3/175 • Number of events 3
|
|
Metabolism and nutrition disorders
malnutrition
|
0.57%
1/175 • Number of events 1
|
|
Cardiac disorders
minor myocardial infarction
|
0.57%
1/175 • Number of events 1
|
|
General disorders
noise hypersensibility
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
non-cardiac death
|
0.57%
1/175 • Number of events 1
|
|
Nervous system disorders
non-cardiac death
|
0.57%
1/175 • Number of events 1
|
|
Surgical and medical procedures
pacemaker/ICD exchange/repositioning
|
1.7%
3/175 • Number of events 3
|
|
Surgical and medical procedures
pericardial effusion and pericardectomy
|
0.57%
1/175 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pocket haematoma
|
2.3%
4/175 • Number of events 4
|
|
Nervous system disorders
spinal disease
|
2.3%
4/175 • Number of events 4
|
|
Vascular disorders
stroke
|
0.57%
1/175 • Number of events 1
|
Other adverse events
| Measure |
Pacemaker Therapy
n=175 participants at risk
Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
|
|---|---|
|
General disorders
Others
|
6.3%
11/175 • Number of events 11
|
|
Cardiac disorders
circulation problems
|
1.1%
2/175 • Number of events 2
|
|
Gastrointestinal disorders
gastrointestinal disease
|
1.7%
3/175 • Number of events 3
|
|
Surgical and medical procedures
lead dislocation
|
1.1%
2/175 • Number of events 2
|
|
Cardiac disorders
pacemaker related
|
5.7%
10/175 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place