Cryptogenic Symptomatic Transient Ischemic AttackPhase 4CRYSTAL-AFNCT00924638
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
A Phase 4 study testing Reveal® XT Insertable Cardiac Monitor in people with Cryptogenic Symptomatic Transient Ischemic Attack and Cryptogenic Ischemic Stroke, run by Medtronic Cardiac Rhythm and Heart Failure at 55 sites in 14 countries.
Trial summary
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cryptogenic Symptomatic Transient Ischemic Attack, Cryptogenic Ischemic Stroke
- What is being tested?
- Reveal® XT Insertable Cardiac Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 55 sitesin 14 countries
- Study dates
- Jun 2009to May 2013
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
Who cannot join
- Known etiology of TIA or stroke.
- Untreated hyperthyroidism.
- Myocardial infarction less than 1 month prior to stroke or TIA.
- Coronary bypass grafting less than 1 month prior to stroke or TIA.
- Valvular disease requiring immediate surgical intervention.
- History of AF or atrial flutter.
Show all 14Show fewer
- Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
- Permanent indication for OAC at enrollment.
- Permanent contra-indication for OAC.
- Included in another clinical trial.
- Life expectancy less than 1 year.
- Pregnant.
- Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
- Not fit, unable or unwilling to follow the required procedures of the protocol.
Trial locations and contacts
55 sites in 14 countries.
55 sites in 14 countries
United States19 sites
Northwestern Memorial Hospital
Chicago, Illinois
Ohio Health Research
Columbus, Ohio
Baylor Research Institute
Dallas, Texas
University of Texas - Southwestern Medical Center
Dallas, Texas
South Denver Cardiology / Swedish Medical Center
Denver, Colorado
Iowa Heart / Ruan Neurology
Des Moines, Iowa
Central Bucks Specialists / Doylestown Hospital
Doylestown, Pennsylvania
Sacred Heart Medical Center
Eugene, Oregon
Greenville Hospital System Cardiology/Cardiovascular Research
Greenville, South Carolina
Hackensack University Medical Center
Hackensack, New Jersey
Mid America Heart Institute / St. Lukes Hospital
Kansas City, Missouri
Louisville Cardiology
Louisville, Kentucky
El Camino Hospital
Mountain View, California
St. Thomas Research Institute
Nashville, Tennessee
Thomas Jefferson University
Philadelphia, Pennsylvania
Washington University Medical School
St Louis, Missouri
Cardiology Associates Research, LLC
Tupelo, Mississippi
Forsyth Medical Center
Winston-Salem, North Carolina
Lankenau
Wynnewood, Pennsylvania
Germany10 sites
Knappschaftskrankenhaus Bochum
Bochum
Klinikum Coburg GmbH
Coburg, Bavaria
Klinikum Dortmund
Dortmund
Universitätsklinikum Essen
Essen
UMG, Goettingen
Göttingen
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
Greifswald
Asklepios Altona
Hamburg
Asklepios Barmbek
Hamburg
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe
Kreiskrankenhaus Rastatt
Rastatt
Belgium4 sites
UZ Antwerpen
Antwerp
Brussels Heart Center (St. Lean - St. Pierre)
Brussels
UZ Leuven
Leuven
Cliniques Universitaires UCL Mont-Godinne
Mont Godinne
Italy4 sites
Ospedale Misericordia di Grosseto
Grosseto
Ospedale di Imperia
Imperia
Policlinico Universitario Agostino Gemelli
Rome
Ospedale Bolognini
Seriate
Austria3 sites
LKH Universitätsklinikum Graz
Graz
AKH Linz
Linz
Landesklinikum Donauregion Tulln
Tulln
France3 sites
Hôpital Saint André -CHU de Bordeaux
Bordeaux
Clinique Parly II - Centre Hospitalier de Versailles
Le Chesnay
Hôpital de la Timone
Marseille
Netherlands3 sites
Atrium Medisch Centrum
Heerlen
St. Antonius Ziekenhuis
Nieuwegein
UMC Utrecht
Utrecht
Canada2 sites
Hamilton Health Sciences / Hamilton General Hospital
Hamilton, Ontario
CHUS / Hopital Fleurimont
Sherbrooke, Quebec
About this study
Official title: CRYptogenic STroke And underLying AF Trial
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.
- Being tested
- Reveal® XT Insertable Cardiac Monitor
- Keywords
- atrial fibrillation, cryptogenic stroke, continuous monitoring, implantable loop recorder, insertable cardiac monitor
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal® XT Insertable Cardiac MonitorDevice
Also called Reveal® XT
The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Monitoring | Active comparator | Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Receives: Device: Reveal® XT Insertable Cardiac Monitor |
| Control Arm | No intervention | Follow-up at the same frequency, but with no Insertable Cardiac Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF Detection Rate Within 6 Months
Percentage of subjects with AF detected within 6 months of follow-up
Measured: 6 months
Secondary outcomes (7)
AF Detection Rate Within 12 Months
Percentage of subjects with AF detected within 12 months of follow-up
Measured: 12 months
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)
Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
Measured: 12 months
Use of Oral Anticoagulation (OAC) Drugs
Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
Measured: 12 months
Use of Antiarrhythmic Drugs
Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
Measured: 12 months
Health Outcome as Evaluated by EQ-5D Questionnaire
EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).
Measured: 12 months
Clinical Disease Burden and Care Pathway
Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
Measured: 12 months
Impact of Patient Assistant Use on AF Diagnosis
AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency
Measured: Follow-up closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionMay 2013
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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cryptogenic Symptomatic Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Brachmann, MD, Principal investigator, Klinikum Coburg, GermanyTommaso Sanna, MD, Principal investigator, Catholic University, ItalyHans Christoph Diener, MD, Principal investigator, Klinik für Neurologie, Essen, GermanyCarlos Morillo, MD, Principal investigator, McMaster Clinic, Hamilton, Ontario, CanadaRichard Bernstein, MD, PhD, Principal investigator, Davee Department of Neurology, Chicago, IL USAVincenzo Di Lazzaro, MD, Principal investigator, Catholic University Rome, Rome ItalyRod Passman, MD, Principal investigator, Northwestern Memorial Hospital, Chicago, IL USAMarilyn Rymer, MD, Principal investigator, St. Lukes Hospital of Kansas City, Kansas City, MI USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924638
- Sponsor's protocol ID
- CRYSTAL-AF
- Acronym
- CRYSTAL-AF
- Status last verified
- Jan 2014
- First submitted
- 17 Jun 2009
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617. doi: 10.1161/01.STR.0000199147.30016.74.
PubMed 16432246Sinha AM, Diener HC, Morillo CA, Sanna T, Bernstein RA, Di Lazzaro V, Passman R, Beckers F, Brachmann J. Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale. Am Heart J. 2010 Jul;160(1):36-41.e1. doi: 10.1016/j.ahj.2010.03.032.
PubMed 20598970Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2022 Mar;65(2):101540. doi: 10.1016/j.rehab.2021.101540. Epub 2021 Nov 13.
PubMed 33984539Witte KK, Tsivgoulis G, Reynolds MR, Tsintzos SI, Eggington S, Ismyrloglou E, Lyon J, Huynh M, Egea M, de Brouwer B, Ziegler PD, Franco N, Joglekar R, Rosemas SC, Liu S, Thijs V. Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation. BMC Cardiovasc Disord. 2021 Mar 31;21(1):160. doi: 10.1186/s12872-021-01967-x.
PubMed 33789592Verma N, Ziegler PD, Liu S, Passman RS. Incidence of atrial fibrillation among patients with an embolic stroke of undetermined source: Insights from insertable cardiac monitors. Int J Stroke. 2019 Feb;14(2):146-153. doi: 10.1177/1747493018798554. Epub 2018 Sep 10.
PubMed 30196791Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.
PubMed 26763225Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11.
PubMed 26182860Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
PubMed 24963567
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRYptogenic STroke And underLying AF Trial
- ClinicalTrials.gov ID
- NCT00924638
- Acronym / sponsor ID
- CRYSTAL-AF / CRYSTAL-AF
- Keywords
- atrial fibrillation, cryptogenic stroke, continuous monitoring, implantable loop recorder, insertable cardiac monitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Monitoring | Active comparator | Device: Reveal® XT Insertable Cardiac MonitorContinuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor |
| Control Arm | No intervention | –Follow-up at the same frequency, but with no Insertable Cardiac Monitor |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
Key exclusion criteria (14 listed)
- Known etiology of TIA or stroke.
- Untreated hyperthyroidism.
- Myocardial infarction less than 1 month prior to stroke or TIA.
- Coronary bypass grafting less than 1 month prior to stroke or TIA.
- Valvular disease requiring immediate surgical intervention.
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 |
|---|---|---|
| Reveal® XT Insertable Cardiac MonitorAlso: Reveal® XTThe Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia. | Device | Continuous Monitoring |
Primary outcome
AF Detection Rate Within 6 Months
Time frame: 6 months
Percentage of subjects with AF detected within 6 months of follow-up
7 secondary outcomes
AF Detection Rate Within 12 Months
Time frame: 12 months
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)
Time frame: 12 months
Use of Oral Anticoagulation (OAC) Drugs
Time frame: 12 months
Use of Antiarrhythmic Drugs
Time frame: 12 months
Health Outcome as Evaluated by EQ-5D Questionnaire
Time frame: 12 months
Clinical Disease Burden and Care Pathway
Time frame: 12 months
Impact of Patient Assistant Use on AF Diagnosis
Time frame: Follow-up closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16432246Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617. doi: 10.1161/01.STR.0000199147.30016.74.
- Background: PubMed 20598970Sinha AM, Diener HC, Morillo CA, Sanna T, Bernstein RA, Di Lazzaro V, Passman R, Beckers F, Brachmann J. Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale. Am Heart J. 2010 Jul;160(1):36-41.e1. doi: 10.1016/j.ahj.2010.03.032.
- Derived from this study: PubMed 33984539Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2022 Mar;65(2):101540. doi: 10.1016/j.rehab.2021.101540. Epub 2021 Nov 13.
- Derived from this study: PubMed 33789592Witte KK, Tsivgoulis G, Reynolds MR, Tsintzos SI, Eggington S, Ismyrloglou E, Lyon J, Huynh M, Egea M, de Brouwer B, Ziegler PD, Franco N, Joglekar R, Rosemas SC, Liu S, Thijs V. Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation. BMC Cardiovasc Disord. 2021 Mar 31;21(1):160. doi: 10.1186/s12872-021-01967-x.
- Derived from this study: PubMed 30196791Verma N, Ziegler PD, Liu S, Passman RS. Incidence of atrial fibrillation among patients with an embolic stroke of undetermined source: Insights from insertable cardiac monitors. Int J Stroke. 2019 Feb;14(2):146-153. doi: 10.1177/1747493018798554. Epub 2018 Sep 10.
- Derived from this study: PubMed 26763225Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.
- Derived from this study: PubMed 26182860Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11.
- Derived from this study: PubMed 24963567Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
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.
Johannes Brachmann, MD principal investigator
Klinikum Coburg, Germany
Tommaso Sanna, MD principal investigator
Catholic University, Italy
Hans Christoph Diener, MD principal investigator
Klinik für Neurologie, Essen, Germany
55 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reveal® XT Insertable Cardiac Monitor in people with Cryptogenic Symptomatic Transient Ischemic Attack and Cryptogenic Ischemic Stroke, run by Medtronic Cardiac Rhythm and Heart Failure at 55 sites in 14 countries.
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 1 inclusion and 14 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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Germany, Belgium, Italy, Austria and 9 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2014). 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?
AF Detection Rate Within 6 Months (time frame: 6 months). 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 NCT00924638, which also lists 8 linked publications.
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 28 Jul 2014.