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

NCT01108692 | Completed DMC

• 1 other identifier: HS053
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 57

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.

Conditions

Atrial Fibrillation; Atrial Flutter; Atrial Tachycardia

Keywords

atrial fibrillation; supraventricular arrhythmia; antithrombotic treatment; antiarrhythmic drugs; medical reaction time; telecardiology; early detection; holters memories; Pacemaker

Outcome Measures

Primary Outcomes (1)

• 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.

  12-month

Secondary Outcomes (7)

• Serious adverse events related to supraventricular arrhythmia.

  12-month

• Atrial burden at the end of the study

  12-month

• Atrial burden related to time

  12-month

• Supraventricular arrhythmia prevalence

  12-month

• Number of patients with managed supraventricular arrhythmia

  12-month

Study Arms (2)

Active

EXPERIMENTAL

Patients will be followed by telecardiology.

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.

Other: Telecardiology

Interventions

Telecardiology OTHER

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.

Also known as: Home-Monitoring, Remote monitoring

Active; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik France: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (57)

CH Général d'Abbeville

Abbeville, France

Location

CH du Pays d'Aix

Aix-en-Provence, France

Location

CH de la région d'Annecy

Annecy, France

Location

CH d'Argentueil

Argenteuil, France

Location

CH d'ARRAS

Arras, France

Location

CH d'AURILLAC

Aurillac, France

Location

CH d'AUXERRE

Auxerre, France

Location

CH d'AVIGNON

Avignon, France

Location

CH de Béziers

Béziers, France

Location

CH de Blois

Blois, France

Location

Centre Hospitalier Jacques Coeur

Bourges, 18016, France

Location

Hôpital Sainte Camille

Bry-sur-Marne, France

Location

CH de Cannes

Cannes, France

Location

CH de Castres

Castres, France

Location

CH William Morey

Chalon-sur-Saône, France

Location

Les Hôpitaux de Chartres

Chartres, France

Location

CH de CHATEAUROUX

Châteauroux, France

Location

CH Public du Cotentin

Cherbourg, France

Location

HIA Percy

Clamart, France

Location

CHG Louis Pasteur

Colmar, France

Location

Hôpital Schweitzer

Colmar, France

Location

CH DINAN

Dinan, France

Location

CH de DOLE

Dole, France

Location

CH de DOUARNENEZ

Douarnenez, France

Location

CHI Eure-Seine

Évreux, France

Location

CH de Firminy

Firminy, France

Location

CH d'HAGUENAU

Haguenau, France

Location

CH de Jonzac

Jonzac, France

Location

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, 85925, France

Location

CH Saint Louis

La Rochelle, France

Location

CH de Lagny

Lagny-sur-Marne, France

Location

CH de LAVAL

Laval, France

Location

CH A.Mignot

Le Chesnay, France

Location

CH du Mans

Le Mans, France

Location

CH de Lens

Lens, France

Location

Groupe Hospitalier de l'Institut catholique de Lille

Lomme, France

Location

CH de Longjumeau

Longjumeau, France

Location

CH Bretagne Sud

Lorient, France

Location

CHR Notre Dame de bon secours

Metz, France

Location

CH de MONTAUBAN

Montauban, France

Location

CH de MONTBELIARD

Montbéliard, France

Location

CH Jean Bouveri

Montceau-les-Mines, France

Location

Intercommunal General Hospital LE RAINCY- MONTFERMEIL

Montfermeil, 93370, France

Location

CHR d'ORLEANS

Orléans, France

Location

CH François Mitterand

Pau, France

Location

CH de Roubaix

Roubaix, France

Location

CH de SAINT BRIEUC

Saint-Brieuc, France

Location

CHI du Val d'Ariège

Saint-Jean-de-Verges, France

Location

CH de Saintonge

Saintes, France

Location

CH de SAINT-MALO

St-Malo, France

Location

CH Metz-Thionville Bel Air

Thionville, France

Location

CH de TOULON

Toulon, France

Location

CH de TROYES

Troyes, France

Location

CH de Valence

Valence, France

Location

CH de Valenciennes

Valenciennes, France

Location

CH Bretagne Atlantique

Vannes, France

Location

CHI de Villeneuve

Villeneuve-Saint-Georges, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Blood Glucose Self-Monitoring; Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Walid AMARA, MD

  Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

FR (57)