IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm. (IES-ACap)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. [ Time Frame: 12 months ]
Secondary Outcome Measures :
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820.
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.
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.