Study of New Implantable Loop Recorder

Syncope Clinical Trial

Official title:

Confirm Implantable Cardiac Monitor Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746564
• Other study ID #: 60020941D
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: June 2014

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2014
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias

• Patients who experience transient symptoms that may suggest a cardiac arrhythmia

• Patients who have been previously diagnosed with atrial fibrillation

• Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented

• Patients who have provided written informed consent to participate in the study.

Exclusion Criteria:

• Patients who are under the age of 18 years

• Patients who have a life expectancy less than 1 year

• Patients who are unable to comply with the follow-up schedule

• Patients who are currently implanted with a pacemaker or defibrillator

• Patients who the physician deems inappropriate for the study

Related Conditions & MeSH terms

• Syncope
• Tachyarrhythmias
• Tachycardia

Intervention

Device:
• SJM Confirm
All patients in this study will receive the SJM Confirm device.

Locations

Country	Name	City	State
United States	Alaska Heart Institute	Anchorage	Alaska
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	University of Virginia	Charlottesville	Virginia
United States	St. Jude Hospital	Fullerton	California
United States	Scripps Clinic	La Jolla	California
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Providence- St Vincent Medical Center	Portland	Oregon
United States	Arizona Arrhythmia Research	Scottsdale	Arizona
United States	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interpretability of Weekly Subject Activator Recordings	The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.	6 weeks
Other	Interpretability of Automatically Triggered/Symptom Driven Recordings	The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.	6 weeks
Other	Inappropriateness of Automatically Triggered Recordings - Phase I	The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.	6 weeks
Other	Inappropriateness of Automatically Triggered Recordings - Phase II	The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.	6 weeks
Primary	Sensitivity for R Waves During In-Clinic Recordings at Rest	The sensitivity was calculated for each recording and for each subject.	6 weeks
Primary	Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise	The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.	6 weeks
Primary	Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers	The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.	6 weeks
Primary	Positive Predictive Value (PPV) for In-Clinic Recordings at Rest	The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.	6 weeks
Primary	Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test	The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.	6 weeks
Primary	Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers	The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.	6 weeks