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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00832260
• Collaborator: (none)
• Enrollment: 70
• Duration (Months): 56

Study Details

Study Description

Brief Summary

The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

Condition or Disease	Intervention/Treatment	Phase
Sinus Bradycardia; Sinus Node Disease; Atrio-ventricular Block

Detailed Description

The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Sep 1, 2013

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. [12 months]

Secondary Outcome Measures

1. 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). [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has an indication for implantation of a dual-chamber pacemaker;

• Patient is older than 18 years of age

• Patient has signed the study specific Informed consent document.

• Primo implant.

Exclusion Criteria:

• Patient is pregnant or nursing

• Patient is less than 18 years of age

• Patient is in New York Heart Association (NYHA) class III and IV.

• Patient has a pacemaker replacement;

• Patient is unable to attend the follow-up visits;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: José Olagüe de Ros, PhD., Hospital Universitario La Fe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00832260
• Other Study ID Numbers: CR08004ES
• First Posted: Jan 30, 2009
• Last Update Posted: Feb 20, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Bradycardia; Sick Sinus Syndrome; Atrioventricular Block

Study Results

Participant Flow

Arm/Group Title	Zephyr Pacemaker
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

Baseline Characteristics

Arm/Group Title	Zephyr Pacemaker
Arm/Group Description	Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Overall Participants	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73 (8.4)
Sex: Female, Male (Count of Participants)
Female	29 41.4%
Male	41 58.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zephyr Pacemaker
Arm/Group Description	Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Measure Participants	70
Number [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).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zephyr Pacemaker
Arm/Group Description	Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
Measure Participants	70
Number [percentage of patients]	21.4

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	Serious Adverse Events were collected
Arm/Group Title	Zephyr Pacemaker
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Zephyr Pacemaker
	Affected / at Risk (%)	# Events
Total	18/70 (25.7%)
Cardiac disorders
Implant of a Percutaneous transluminal coronary angioplasty (PTCA)	1/70 (1.4%)	1
Myocardial infarction	1/70 (1.4%)	1
Palpitations	1/70 (1.4%)	1
Stent	1/70 (1.4%)	1
Thoracic pain	1/70 (1.4%)	1
Death	1/70 (1.4%)	1
Atrial Flutter	1/70 (1.4%)	1
Palpitations	1/70 (1.4%)	1
Ear and labyrinth disorders
Transtympanic drain	1/70 (1.4%)	1
Gastrointestinal disorders
Hemorrhoids surgery	1/70 (1.4%)	1
Hepatobiliary disorders
Cholangitis	1/70 (1.4%)	1
Immune system disorders
Decrease in immunological system	1/70 (1.4%)	1
Infections and infestations
Possible strange body in a wound.	1/70 (1.4%)	1
Musculoskeletal and connective tissue disorders
Hernioplasty	1/70 (1.4%)	1
Nervous system disorders
Pyramidal Syndrome	1/70 (1.4%)	1
Psychiatric disorders
Bipolar disorder	1/70 (1.4%)	1
Seizure crisis	1/70 (1.4%)	1
Seizure crisis	1/70 (1.4%)	1
Renal and urinary disorders
Macroscopic Hematuria	1/70 (1.4%)	2
Reproductive system and breast disorders
Prostatectomy	1/70 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Tracheotomy	1/70 (1.4%)	1
Dyspnea	1/70 (1.4%)	2
Pneumothorax	1/70 (1.4%)	1
Vascular disorders
Cerebral Hemorrhage	1/70 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Zephyr Pacemaker
	Affected / at Risk (%)	# Events
Total	0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.