Trial Outcomes & Findings for Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients (NCT NCT00932659)

NCT ID: NCT00932659

Last Updated: 2013-04-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 8 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2013-04-19

Participant Flow

Patients recruited from June 2009 to August 2010

Participant milestones

Measure	Single Arm: Hemodialysis Patients Implanted With REVEAL Device adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

Baseline characteristics by cohort

Measure	Single Arm: Hemodialysis Patients Implanted With REVEAL Device n=8 Participants adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All patients enrolled were analyzed in this observational study.

Outcome measures

Measure	Single Arm: Hemodialysis Patients Implanted With REVEAL Device n=8 Participants adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
Number of Participants With a Significant Arrhythmia Detected	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: all participants included

Outcome measures

Measure	Single Arm: Hemodialysis Patients Implanted With REVEAL Device n=8 Participants adult hemodialysis patients without a prior history of cardiac arrhythmias continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias	0 participants

Adverse Events

Single Arm: Hemodialysis Patients Implanted With REVEAL Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patrick Pun, MD, MHS

Duke University

Phone: 919-660-6865

Email: patrick.pun@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place