ULTRA Study for Pacemaker Patients

Boston Scientific

Status and phase

Completed

Phase 4

Conditions

Bradycardia

Treatments

Device: Pacemaker with Automatic Capture

Study type

Interventional

Funder types

Industry

Identifiers

NCT00133289

CR-CA-051205-B

Details and patient eligibility

About

The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who meet current INSIGNIA® Ultra pacemaker indications
Patients who will be programmed to a pacing mode of DDD, DDDR, VVI, VVIR, or VDD at the time of implant
Patients who sign and date a Patient Informed Consent form at or prior to the implant visit
Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion criteria

Patients who will receive a single chamber device with an atrial lead only
Patients who have chronic leads with a ventricular threshold of more than 4.0 V
Patients whose life expectancy is less than 12 months
Patients who are expected to receive a heart transplant during the duration of the study
Patients who have or who are likely to receive a tricuspid valve prosthesis
Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the ULTRA study.
Patients who are younger than 18 years of age
Patients who are pregnant
Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study