TachyarrhythmiasNCT00746564

Study of New Implantable Loop Recorder

A study testing SJM Confirm in people with Tachyarrhythmias and Syncope, run by Abbott Medical Devices at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tachyarrhythmias, Syncope
What is being tested?: SJM Confirm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 9 sitesUnited States
Study dates: Sep 2008to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Alaska Heart Institute
Anchorage, Alaska, 99508
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Virginia
Charlottesville, Virginia, 22980
St. Jude Hospital
Fullerton, California, 92835-2605
Scripps Clinic
La Jolla, California, 92037
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Providence- St Vincent Medical Center
Portland, Oregon, 97225
Arizona Arrhythmia Research
Scottsdale, Arizona, 85251
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: Confirm Implantable Cardiac Monitor Study

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).

Conditions: Tachyarrhythmias, Syncope
Being tested: SJM Confirm
Keywords: Implantable Cardiac Monitor, Arrhythmias, Atrial Fibrillation
Medical subject headings: Tachycardia, Syncope, Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SJM ConfirmDevice
All patients in this study will receive the SJM Confirm device.

Study groups in NCT00746564
Study group	Role	What they receive
Open Label	Experimental	SJM Confirm Device Receives: Device: SJM Confirm

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity for R Waves During In-Clinic Recordings at Rest
The sensitivity was calculated for each recording and for each subject.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jun 2014

First posted4 Sep 2008 (estimated)
Study startSep 2008
Primary completionFeb 2011
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TachyarrhythmiasStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00746564
Sponsor's protocol ID: 60020941D
Status last verified: Jan 2019
First submitted: 2 Sep 2008
Last updated: 30 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Confirm Implantable Cardiac Monitor Study
ClinicalTrials.gov ID: NCT00746564
Acronym / sponsor ID: 60020941D
Conditions: Tachyarrhythmias, Syncope
Keywords: Implantable Cardiac Monitor, Arrhythmias, Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Feb 2011 (actual)
Study completion: Jun 2014 (actual)
First posted: 4 Sep 2008 (estimated)
Results: Posted 30 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open Label	Experimental	Device: SJM ConfirmSJM Confirm Device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SJM ConfirmAll patients in this study will receive the SJM Confirm device.	Device	Open Label

Primary outcome

Sensitivity for R Waves During In-Clinic Recordings at Rest
Time frame: 6 weeks
The sensitivity was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
Time frame: 6 weeks
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
Time frame: 6 weeks
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
Time frame: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
Time frame: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
Time frame: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.

Results and safety

Results posted to the registry on 30 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SJM Confirm Device	75	73

Primary outcome: Sensitivity for R Waves During In-Clinic Recordings at Rest

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: percentage of recordings

Measure	SJM Confirm Device n = 48
Value	100 (100 to 100)

SJM Confirm Device: percentage of recordings: 100 (95% CI 100 to 100)

Population analysed: 50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).

Primary outcome: Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: percentage of recordings

Measure	SJM Confirm Device n = 46
Value	98.1 (95.7 to 100)

SJM Confirm Device: percentage of clinical recordings: 98.1 (95% CI 95.7 to 100)

Population analysed: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).

Primary outcome: Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: percentage of recordings

Measure	SJM Confirm Device n = 48
Value	98.0 (95.5 to 100)

SJM Confirm Device: percentage of recordings: 98.0 (95% CI 95.5 to 100)

Population analysed: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings

Primary outcome: Positive Predictive Value (PPV) for In-Clinic Recordings at Rest

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: percentage of recordings

Measure	SJM Confirm Device n = 48
Value	98.9 (96.7 to 100)

SJM Confirm Device: percentage of recordings: 98.9 (95% CI 96.7 to 100)

Population analysed: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.

Adverse events

Time frame: Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SJM Confirm Device	11 of 75 (14.7%)	14 of 75 (18.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tachyarrhythmias

Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
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Recruiting
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
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RecruitingPhase 4
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RecruitingPhase 1
Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tamara Shipman study director

Abbott Medical Devices

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SJM Confirm in people with Tachyarrhythmias and Syncope, run by Abbott Medical Devices at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity for R Waves During In-Clinic Recordings at Rest (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00746564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.