Atrial FibrillationSETAMNCT01108692
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
A study testing Telecardiology in people with Atrial Fibrillation and Atrial Flutter, run by Biotronik France at 57 sites in France.
Trial summary
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- What is being tested?
- Telecardiology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 57 sitesFrance
- Study dates
- Jul 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Dual chamber pacemaker with activated Telecardiology
- CHAD2DS2-VASc score ≥ 2
- Sinusal rhythm at enrollment
- Patient willing and able to comply with the protocol
- Patient has provided informed consent
- Men and women > 18 years-old
- Patients geographically stable
Who cannot join
- Anticoagulation therapy
- Dual anti-platelet therapy
- Class I or class III anti-arrhythmic drugs
- Contraindication to antithrombotic therapy
- Participation in another clinical study
- Have a life expectancy < 6 months
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
France57 sites
CH Général d'Abbeville
Abbeville
CH du Pays d'Aix
Aix-en-Provence
CH de la région d'Annecy
Annecy
CH d'Argentueil
Argenteuil
CH d'ARRAS
Arras
CH d'AURILLAC
Aurillac
CH d'AUXERRE
Auxerre
CH d'AVIGNON
Avignon
CH de Béziers
Béziers
CH de Blois
Blois
Centre Hospitalier Jacques Coeur
Bourges, 18016
Hôpital Sainte Camille
Bry-sur-Marne
CH de Cannes
Cannes
CH de Castres
Castres
CH William Morey
Chalon-sur-Saône
Les Hôpitaux de Chartres
Chartres
CH de CHATEAUROUX
Châteauroux
CH Public du Cotentin
Cherbourg
HIA Percy
Clamart
CHG Louis Pasteur
Colmar
Hôpital Schweitzer
Colmar
CH DINAN
Dinan
CH de DOLE
Dole
CH de DOUARNENEZ
Douarnenez
CHI Eure-Seine
Évreux
CH de Firminy
Firminy
CH d'HAGUENAU
Haguenau
CH de Jonzac
Jonzac
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, 85925
CH Saint Louis
La Rochelle
CH de Lagny
Lagny-sur-Marne
CH de LAVAL
Laval
CH A.Mignot
Le Chesnay
CH du Mans
Le Mans
CH de Lens
Lens
Groupe Hospitalier de l'Institut catholique de Lille
Lomme
CH de Longjumeau
Longjumeau
CH Bretagne Sud
Lorient
CHR Notre Dame de bon secours
Metz
CH de MONTAUBAN
Montauban
CH de MONTBELIARD
Montbéliard
CH Jean Bouveri
Montceau-les-Mines
Intercommunal General Hospital LE RAINCY- MONTFERMEIL
Montfermeil, 93370
CHR d'ORLEANS
Orléans
CH François Mitterand
Pau
CH de Roubaix
Roubaix
CH de SAINT BRIEUC
Saint-Brieuc
CHI du Val d'Ariège
Saint-Jean-de-Verges
CH de Saintonge
Saintes
CH de SAINT-MALO
St-Malo
CH Metz-Thionville Bel Air
Thionville
CH de TOULON
Toulon
CH de TROYES
Troyes
CH de Valence
Valence
CH de Valenciennes
Valenciennes
CH Bretagne Atlantique
Vannes
CHI de Villeneuve
Villeneuve-Saint-Georges
About this study
Official title: Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
The primary endpoint investigates the delay to implement treatment in two groups of patients :
- Active group: Patients followed by telecardiology.
- Control group: Patients followed in the conventional manner.
It is assumed that the delay to implement treatment will be higher in the Control group.
Read the detailed description
Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter.
This study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Being tested
- Telecardiology
- Keywords
- atrial fibrillation, supraventricular arrhythmia, antithrombotic treatment, antiarrhythmic drugs, medical reaction time, telecardiology, early detection, holters memories, Pacemaker
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelecardiologyOther
Also called Home-Monitoring, Remote monitoring
Telecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician.
A retrospective analysis will be performed at the end of the study to compare the results in the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Patients will be followed by telecardiology. Receives: Other: Telecardiology |
| Control | Active comparator | Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance. Receives: Other: Telecardiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
Measured: 12-month
Secondary outcomes (7)
Serious adverse events related to supraventricular arrhythmia.
Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
Measured: 12-month
Atrial burden at the end of the study
Measured: 12-month
Atrial burden related to time
In order to check if atrial burden is time-dependent.
Measured: 12-month
Supraventricular arrhythmia prevalence
Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
Measured: 12-month
Number of patients with managed supraventricular arrhythmia
Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
Measured: 12-month
Supraventricular arrhythmia symptoms score (via a questionnaire)
Questionnaire submitted to the patient at enrollment and at each follow-up visit.
Measured: at each follow-up visit
Quality of Life (via the EQ-5D Questionnaire)
The general health perception of the patients will be asked for, via the standardized EuroQOL EQ-5D questionnaire. This questionnaire provides a descriptive profile covering five dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) as well as a self-rating score of the patient's own assessment of its heath status.
Measured: at each follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Walid AMARA, MD, Principal investigator, Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108692
- Sponsor's protocol ID
- HS053
- Acronym
- SETAM
- Status last verified
- Dec 2013
- First submitted
- 21 Apr 2010
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology
- ClinicalTrials.gov ID
- NCT01108692
- Acronym / sponsor ID
- SETAM / HS053
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Keywords
- atrial fibrillation, supraventricular arrhythmia, antithrombotic treatment, antiarrhythmic drugs, medical reaction time, telecardiology, early detection, holters memories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Biotronik FranceIndustry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
The primary endpoint investigates the delay to implement treatment in two groups of patients :
- Active group: Patients followed by telecardiology.
- Control group: Patients followed in the conventional manner.
It is assumed that the delay to implement treatment will be higher in the Control group.
Detailed description
Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter.
This study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: TelecardiologyPatients will be followed by telecardiology. |
| Control | Active comparator | Other: TelecardiologyPatients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Dual chamber pacemaker with activated Telecardiology
- CHAD2DS2-VASc score ≥ 2
- Sinusal rhythm at enrollment
- Patient willing and able to comply with the protocol
- Patient has provided informed consent
Key exclusion criteria (6 listed)
- Anticoagulation therapy
- Dual anti-platelet therapy
- Class I or class III anti-arrhythmic drugs
- Contraindication to antithrombotic therapy
- Participation in another clinical 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 |
|---|---|---|
| TelecardiologyAlso: Home-Monitoring, Remote monitoringTelecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician. A retrospective analysis will be performed at the end of the study to compare the results in the two groups. | Other | Active, Control |
Primary outcome
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
Time frame: 12-month
Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
7 secondary outcomes
Serious adverse events related to supraventricular arrhythmia.
Time frame: 12-month
Atrial burden at the end of the study
Time frame: 12-month
Atrial burden related to time
Time frame: 12-month
Supraventricular arrhythmia prevalence
Time frame: 12-month
Number of patients with managed supraventricular arrhythmia
Time frame: 12-month
Supraventricular arrhythmia symptoms score (via a questionnaire)
Time frame: at each follow-up visit
Quality of Life (via the EQ-5D Questionnaire)
Time frame: at each follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Walid AMARA, MD principal investigator
Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telecardiology in people with Atrial Fibrillation and Atrial Flutter, run by Biotronik France at 57 sites in France.
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 7 inclusion and 6 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 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia. (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2013.