Trial Outcomes & Findings for IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm. (NCT NCT00832260)
NCT ID: NCT00832260
Last Updated: 2019-02-20
Results Overview
Recruitment status
COMPLETED
Target enrollment
70 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
Zephyr Pacemaker
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Baseline characteristics by cohort
| Measure |
Zephyr Pacemaker
n=70 Participants
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
|
|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Zephyr Pacemaker
n=70 Participants
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
|
|---|---|
|
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
|
61.9 percentage of patients
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Zephyr Pacemaker
n=70 Participants
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
|
|---|---|
|
Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).
|
21.4 percentage of patients
|
Adverse Events
Zephyr Pacemaker
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zephyr Pacemaker
n=70 participants at risk
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
|
|---|---|
|
Cardiac disorders
Implant of a Percutaneous transluminal coronary angioplasty (PTCA)
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Gastrointestinal disorders
Hemorrhoids surgery
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Psychiatric disorders
Bipolar disorder
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Psychiatric disorders
Seizure crisis
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Nervous system disorders
Pyramidal Syndrome
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Cardiac disorders
Palpitations
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Cardiac disorders
Stent
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Cardiac disorders
Thoracic pain
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Ear and labyrinth disorders
Transtympanic drain
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Immune system disorders
Decrease in immunological system
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Tracheotomy
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Musculoskeletal and connective tissue disorders
Hernioplasty
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Vascular disorders
Cerebral Hemorrhage
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Cardiac disorders
Death
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Hepatobiliary disorders
Cholangitis
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/70 • Number of events 2 • 12 months
Serious Adverse Events were collected
|
|
Reproductive system and breast disorders
Prostatectomy
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Cardiac disorders
Atrial Flutter
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
|
Renal and urinary disorders
Macroscopic Hematuria
|
1.4%
1/70 • Number of events 2 • 12 months
Serious Adverse Events were collected
|
|
Infections and infestations
Possible strange body in a wound.
|
1.4%
1/70 • Number of events 1 • 12 months
Serious Adverse Events were collected
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. José Olagüe
Hospital Universitari i politecnic La Fe
Phone: +34 961 24 40 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60