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

This study has been completed.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Biotronik France
ClinicalTrials.gov Identifier:
NCT01108692
First received: April 21, 2010
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Atrial Flutter
Atrial Tachycardia
Other: Telecardiology

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology

Resource links provided by NLM:


Further study details as provided by Biotronik France:

Primary Outcome Measures:
  • Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia. [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency

  • Atrial burden at the end of the study [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
  • Atrial burden related to time [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    In order to check if atrial burden is time-dependent.

  • Supraventricular arrhythmia prevalence [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.

  • Number of patients with managed supraventricular arrhythmia [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: at each follow-up visit ] [ Designated as safety issue: Yes ]
    Questionnaire submitted to the patient at enrollment and at each follow-up visit.

  • Quality of Life (via the EQ-5D Questionnaire) [ Time Frame: at each follow-up visit ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 602
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Patients will be followed by telecardiology.
Other: Telecardiology

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.

Other Names:
  • Home-Monitoring
  • Remote monitoring
Active Comparator: Control
Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.
Other: Telecardiology

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.

Other Names:
  • Home-Monitoring
  • Remote monitoring

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108692

  Show 57 Study Locations
Sponsors and Collaborators
Biotronik France
Biotronik SE & Co. KG
Investigators
Principal Investigator: Walid AMARA, MD Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
  More Information

No publications provided

Responsible Party: Biotronik France
ClinicalTrials.gov Identifier: NCT01108692     History of Changes
Other Study ID Numbers: HS053
Study First Received: April 21, 2010
Last Updated: December 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Biotronik France:
atrial fibrillation
supraventricular arrhythmia
antithrombotic treatment
antiarrhythmic drugs
medical reaction time
telecardiology
early detection
holters memories
Pacemaker
Telecardiology

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Tachycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014