Study of New Implantable Loop Recorder
28. januar 2019 opdateret af: Abbott Medical Devices
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).
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
75
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Heart Institute
-
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85251
- Arizona Arrhythmia Research
-
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72211
- Arkansas Heart Hospital
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California
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Fullerton, California, Forenede Stater, 92835-2605
- St. Jude Hospital
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La Jolla, California, Forenede Stater, 92037
- Scripps Clinic
-
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74104
- Oklahoma Heart Institute at Utica
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- Providence- St Vincent Medical Center
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Texas
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Austin, Texas, Forenede Stater, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22980
- University of Virginia
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Open Label
SJM Confirm Device
|
All patients in this study will receive the SJM Confirm device.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity for R Waves During In-Clinic Recordings at Rest
Tidsramme: 6 weeks
|
The sensitivity was calculated for each recording and for each subject.
|
6 weeks
|
|
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
Tidsramme: 6 weeks
|
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
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6 weeks
|
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Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
Tidsramme: 6 weeks
|
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
|
6 weeks
|
|
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
Tidsramme: 6 weeks
|
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
|
6 weeks
|
|
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
Tidsramme: 6 weeks
|
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
|
6 weeks
|
|
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
Tidsramme: 6 weeks
|
The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
|
6 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Interpretability of Weekly Subject Activator Recordings
Tidsramme: 6 weeks
|
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.
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6 weeks
|
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Interpretability of Automatically Triggered/Symptom Driven Recordings
Tidsramme: 6 weeks
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The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.
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6 weeks
|
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Inappropriateness of Automatically Triggered Recordings - Phase I
Tidsramme: 6 weeks
|
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.
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6 weeks
|
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Inappropriateness of Automatically Triggered Recordings - Phase II
Tidsramme: 6 weeks
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Tamara Shipman, Abbott Medical Devices
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2008
Primær færdiggørelse (Faktiske)
1. februar 2011
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
2. september 2008
Først indsendt, der opfyldte QC-kriterier
3. september 2008
Først opslået (Skøn)
4. september 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 60020941D
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