Overview

This trial is active, not recruiting.

Condition bradyarrhythmia
Sponsor Boston Scientific Corporation
Start date February 2013
End date December 2016
Trial size 500 participants
Trial identifier NCT01715558, CDM00053871 / 90942887

Summary

The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm

Primary Outcomes

Measure
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature
time frame: 2 years

Secondary Outcomes

Measure
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital 2. Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center 3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: 1. Patients with 3rd degree AV block 2. Patients with permanent AF 3. Patients followed up remotely with remote patient management system. 4. Patients who are unable to be followed up by the participating centers for a period of two years 5. Patients who have a current device implanted for more than 15 days 6. Women of childbearing potential who are pregnant, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion) 7. Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol.

Additional Information

Official title Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.