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Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM) (SETAM)

Primary Purpose

Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Telecardiology
Sponsored by
Biotronik France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, supraventricular arrhythmia, antithrombotic treatment, antiarrhythmic drugs, medical reaction time, telecardiology, early detection, holters memories, Pacemaker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CH Général d'Abbeville
  • CH du Pays d'Aix
  • CH de la région d'Annecy
  • CH d'Argentueil
  • CH d'ARRAS
  • CH d'AURILLAC
  • CH d'AUXERRE
  • CH d'AVIGNON
  • CH de Béziers
  • CH de Blois
  • Centre Hospitalier Jacques Coeur
  • Hôpital Sainte Camille
  • CH de Cannes
  • CH de Castres
  • CH William Morey
  • Les Hôpitaux de Chartres
  • CH de CHATEAUROUX
  • CH Public du Cotentin
  • HIA Percy
  • CHG Louis Pasteur
  • Hôpital Schweitzer
  • CH DINAN
  • CH de DOLE
  • CH de DOUARNENEZ
  • CHI Eure-Seine
  • CH de Firminy
  • CH d'HAGUENAU
  • CH de Jonzac
  • CH Saint Louis
  • Centre Hospitalier Départemental Les Oudairies
  • CH de Lagny
  • CH de LAVAL
  • CH A.Mignot
  • CH du Mans
  • CH de Lens
  • Groupe Hospitalier de l'Institut catholique de Lille
  • CH de Longjumeau
  • CH Bretagne Sud
  • CHR Notre Dame de bon secours
  • CH de MONTAUBAN
  • CH de MONTBELIARD
  • CH Jean Bouveri
  • Intercommunal General Hospital LE RAINCY- MONTFERMEIL
  • CHR d'ORLEANS
  • CH François Mitterand
  • CH de Roubaix
  • CHI du Val d'Ariège
  • CH de SAINT BRIEUC
  • CH de SAINT-MALO
  • CH de Saintonge
  • CH Metz-Thionville Bel Air
  • CH de TOULON
  • CH de TROYES
  • CH de Valence
  • CH de Valenciennes
  • CH Bretagne Atlantique
  • CHI de Villeneuve

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Control

Arm Description

Patients will be followed by telecardiology.

Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serious adverse events related to supraventricular arrhythmia.
Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
Atrial burden at the end of the study
Atrial burden related to time
In order to check if atrial burden is time-dependent.
Supraventricular arrhythmia prevalence
Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
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).
Supraventricular arrhythmia symptoms score (via a questionnaire)
Questionnaire submitted to the patient at enrollment and 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.

Full Information

First Posted
April 21, 2010
Last Updated
December 5, 2013
Sponsor
Biotronik France
Collaborators
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01108692
Brief Title
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
Acronym
SETAM
Official Title
Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik France
Collaborators
Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
Keywords
atrial fibrillation, supraventricular arrhythmia, antithrombotic treatment, antiarrhythmic drugs, medical reaction time, telecardiology, early detection, holters memories, Pacemaker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Patients will be followed by telecardiology.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.
Intervention Type
Other
Intervention Name(s)
Telecardiology
Other Intervention Name(s)
Home-Monitoring, Remote monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
Description
Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Serious adverse events related to supraventricular arrhythmia.
Description
Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
Time Frame
12-month
Title
Atrial burden at the end of the study
Time Frame
12-month
Title
Atrial burden related to time
Description
In order to check if atrial burden is time-dependent.
Time Frame
12-month
Title
Supraventricular arrhythmia prevalence
Description
Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
Time Frame
12-month
Title
Number of patients with managed supraventricular arrhythmia
Description
Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
Time Frame
12-month
Title
Supraventricular arrhythmia symptoms score (via a questionnaire)
Description
Questionnaire submitted to the patient at enrollment and at each follow-up visit.
Time Frame
at each follow-up visit
Title
Quality of Life (via the EQ-5D Questionnaire)
Description
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.
Time Frame
at each follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid AMARA, MD
Organizational Affiliation
Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Général d'Abbeville
City
Abbeville
Country
France
Facility Name
CH du Pays d'Aix
City
Aix En Provence
Country
France
Facility Name
CH de la région d'Annecy
City
Annecy
Country
France
Facility Name
CH d'Argentueil
City
Argenteuil
Country
France
Facility Name
CH d'ARRAS
City
Arras
Country
France
Facility Name
CH d'AURILLAC
City
Aurillac
Country
France
Facility Name
CH d'AUXERRE
City
Auxerre
Country
France
Facility Name
CH d'AVIGNON
City
Avignon
Country
France
Facility Name
CH de Béziers
City
Beziers
Country
France
Facility Name
CH de Blois
City
Blois
Country
France
Facility Name
Centre Hospitalier Jacques Coeur
City
Bourges
ZIP/Postal Code
18016
Country
France
Facility Name
Hôpital Sainte Camille
City
Bry Sur Marne
Country
France
Facility Name
CH de Cannes
City
Cannes
Country
France
Facility Name
CH de Castres
City
Castres
Country
France
Facility Name
CH William Morey
City
Chalon Sur Saone
Country
France
Facility Name
Les Hôpitaux de Chartres
City
Chartres
Country
France
Facility Name
CH de CHATEAUROUX
City
Chateauroux
Country
France
Facility Name
CH Public du Cotentin
City
Cherbourg
Country
France
Facility Name
HIA Percy
City
Clamart
Country
France
Facility Name
CHG Louis Pasteur
City
Colmar
Country
France
Facility Name
Hôpital Schweitzer
City
Colmar
Country
France
Facility Name
CH DINAN
City
Dinan
Country
France
Facility Name
CH de DOLE
City
Dole
Country
France
Facility Name
CH de DOUARNENEZ
City
Douarnenez
Country
France
Facility Name
CHI Eure-Seine
City
Evreux
Country
France
Facility Name
CH de Firminy
City
Firminy
Country
France
Facility Name
CH d'HAGUENAU
City
Haguenau
Country
France
Facility Name
CH de Jonzac
City
Jonzac
Country
France
Facility Name
CH Saint Louis
City
La Rochelle
Country
France
Facility Name
Centre Hospitalier Départemental Les Oudairies
City
La-roche-sur-yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH de Lagny
City
LAGNY sur MARNE
Country
France
Facility Name
CH de LAVAL
City
Laval
Country
France
Facility Name
CH A.Mignot
City
Le Chesnay
Country
France
Facility Name
CH du Mans
City
Le Mans
Country
France
Facility Name
CH de Lens
City
Lens
Country
France
Facility Name
Groupe Hospitalier de l'Institut catholique de Lille
City
Lomme
Country
France
Facility Name
CH de Longjumeau
City
Longjumeau
Country
France
Facility Name
CH Bretagne Sud
City
Lorient
Country
France
Facility Name
CHR Notre Dame de bon secours
City
Metz
Country
France
Facility Name
CH de MONTAUBAN
City
Montauban
Country
France
Facility Name
CH de MONTBELIARD
City
Montbeliard
Country
France
Facility Name
CH Jean Bouveri
City
MONTCEAU les MINES
Country
France
Facility Name
Intercommunal General Hospital LE RAINCY- MONTFERMEIL
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
CHR d'ORLEANS
City
Orléans
Country
France
Facility Name
CH François Mitterand
City
PAU
Country
France
Facility Name
CH de Roubaix
City
Roubaix
Country
France
Facility Name
CHI du Val d'Ariège
City
Saint Jean de Verges
Country
France
Facility Name
CH de SAINT BRIEUC
City
Saint-brieuc
Country
France
Facility Name
CH de SAINT-MALO
City
Saint-malo
Country
France
Facility Name
CH de Saintonge
City
Saintes
Country
France
Facility Name
CH Metz-Thionville Bel Air
City
Thionville
Country
France
Facility Name
CH de TOULON
City
Toulon
Country
France
Facility Name
CH de TROYES
City
Troyes
Country
France
Facility Name
CH de Valence
City
Valence
Country
France
Facility Name
CH de Valenciennes
City
Valenciennes
Country
France
Facility Name
CH Bretagne Atlantique
City
Vannes
Country
France
Facility Name
CHI de Villeneuve
City
Villeneuve Saint Georges
Country
France

12. IPD Sharing Statement

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Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)

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