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IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm. (IES-ACap)

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ClinicalTrials.gov Identifier: NCT00832260
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : September 8, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Sinus Bradycardia
Sinus Node Disease
Atrio-ventricular Block
Enrollment 70

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zephyr Pacemaker
Hide Arm/Group Description Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Period Title: Overall Study
Started 70
Completed 70
Not Completed 0
Arm/Group Title Zephyr Pacemaker
Hide Arm/Group Description Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
73  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
29
  41.4%
Male
41
  58.6%
1.Primary Outcome
Title Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zephyr Pacemaker
Hide Arm/Group Description:
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: percentage of patients
61.9
2.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zephyr Pacemaker
Hide Arm/Group Description:
Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: percentage of patients
21.4
Time Frame 12 months
Adverse Event Reporting Description Serious Adverse Events were collected
 
Arm/Group Title Zephyr Pacemaker
Hide Arm/Group Description Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
All-Cause Mortality
Zephyr Pacemaker
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zephyr Pacemaker
Affected / at Risk (%) # Events
Total   18/70 (25.71%)    
Cardiac disorders   
Implant of a Percutaneous transluminal coronary angioplasty (PTCA) * [1]  1/70 (1.43%)  1
Myocardial infarction * [2]  1/70 (1.43%)  1
Palpitations * [3]  1/70 (1.43%)  1
Stent * [4]  1/70 (1.43%)  1
Thoracic pain * [5]  1/70 (1.43%)  1
Death * [6]  1/70 (1.43%)  1
Atrial Flutter * [7]  1/70 (1.43%)  1
Palpitations * [8]  1/70 (1.43%)  1
Ear and labyrinth disorders   
Transtympanic drain * [9]  1/70 (1.43%)  1
Gastrointestinal disorders   
Hemorrhoids surgery * [10]  1/70 (1.43%)  1
Hepatobiliary disorders   
Cholangitis * [11]  1/70 (1.43%)  1
Immune system disorders   
Decrease in immunological system * [12]  1/70 (1.43%)  1
Infections and infestations   
Possible strange body in a wound. * [13]  1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders   
Hernioplasty * [14]  1/70 (1.43%)  1
Nervous system disorders   
Pyramidal Syndrome * [15]  1/70 (1.43%)  1
Psychiatric disorders   
Bipolar disorder * [16]  1/70 (1.43%)  1
Seizure crisis * [17]  1/70 (1.43%)  1
Seizure crisis * [18]  1/70 (1.43%)  1
Renal and urinary disorders   
Macroscopic Hematuria * [19]  1/70 (1.43%)  2
Reproductive system and breast disorders   
Prostatectomy * [20]  1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders   
Tracheotomy * [21]  1/70 (1.43%)  1
Dyspnea * [22]  1/70 (1.43%)  2
Pneumothorax * [23]  1/70 (1.43%)  1
Vascular disorders   
Cerebral Hemorrhage * [24]  1/70 (1.43%)  1
*
Indicates events were collected by non-systematic assessment
[1]
On November 2009 patient was admitted into the hospital due to chest pain. Treated by Percutaneous transluminal coronary angioplasty (PTCA) On March 2010 two stents in middle descendent artery were implanted. We were aware on the 12 month follow-up.
[2]
Exitus – Death due to sudden death 05-jul-2009 (Myocardial infarction)
[3]
Patient was admitted in emergency service of another hospital on 16-jul-2009 due to palpitations.
[4]
Patient is implanted with stent.
[5]
Hospitalization prolonged due to thoracic pain treated with Nitroglycerin.
[6]
Patient did not present at follow-up so state of event was searched. Unknown cause.
[7]
Patient is admitted in emergency service on 10-abr-2010 due to atrial flutter
[8]
Patient is admitted in emergency service due to palpitations. Patient was discharged on the same day of admission.
[9]
Transtympanic drain
[10]
Hemorrhoids surgery. The patient is discharged from hospital the same day (03/12/2009).
[11]
Patient is committed in emergency service on 23-oct-2009 due to acute cholangitis and is discharged on 05-nov-2009. Cholecystectomy performed.
[12]
Patient was hospitalized due to a decrease in immunological system.
[13]
Patient was admitted in emergency service due to possible strange body in a wound.
[14]
Patient was admitted in surgery service to be made a hernioplasty.
[15]
Patient was admitted in neurology service due to pyramidal syndrome.
[16]
Patient was admitted due to a worsening of bipolar disorder during the hospitalization. The device was implanted on the 7th May 2009. Patient was discharged on the 12th May 2009.
[17]
Patient was hospitalized due to seizure crisis from 21st to 28th October 2009.
[18]
Patient was admitted into the hospital on the 13-Apr-2009 due to seizure crisis, during the hospitalization the device was implanted on the 07-may-2009. Patient discharged on the 29-may-2009.
[19]
Macroscopic hematuria due to antiaggregants treatment
[20]
Patient is admitted at hospital to proceed with prostatectomy.
[21]
Patient was admitted in emergency service and he was made a tracheotomy.
[22]
Patient is admitted at emergency service due to dyspnea.
[23]
Pneumothorax tension due to a secondary traumatic punction.
[24]
Patient suffered a cerebral hemorrhage which caused the patient exitus.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zephyr Pacemaker
Affected / at Risk (%) # Events
Total   0/70 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. José Olagüe
Organization: Hospital Universitari i politecnic La Fe
Phone: +34 961 24 40 00
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00832260     History of Changes
Other Study ID Numbers: CR08004ES
First Submitted: January 29, 2009
First Posted: January 30, 2009
Results First Submitted: August 27, 2014
Results First Posted: September 8, 2014
Last Update Posted: October 6, 2014