Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

Heart Failure Clinical Trial

— effecT  

Official title:

Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811382
• Other study ID #: HS044
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: October 23, 2015
• Start date: May 2008
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation as well as the early optimization of cardiac resynchronization therapy via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator backup and atrial fibrillation.

Description:

EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator (ICD) backup (CRT-ICD) and paroxysmal or persistent AF.

300 patients with a documented history of AF will be enrolled and randomized 1:1 to standard patient management or AF management and early optimization of CRT via Home Monitoring. The patient outcome regarding days lost due to cardiovascular mortality, cardiovascular hospitalization and inappropriate ICD therapy will be documented during an observational period of 1 year.

Another 300 patients undergoing CRT-ICD implantation without a history of AF will undergo an AF evaluation during the first three months of CRT. If a patient shows an AF episode during this period, he is eligible for study inclusion. If no AF episode occurs during AF evaluation, the patient be treated as screening failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for CRT with ICD-backup

• Paroxysmal or persistent AF

• Optimized HF-related medication

Exclusion Criteria:

• Permanent AF

• Contraindication for anticoagulation

• Stroke within the last 6 weeks

• Acute coronary syndrome within the last 2 months

• Cardiac surgery within the last 2 months

• Acute myocarditis

• Severe chronic obstructive pulmonary disease

• Planned cardiac surgery or interventional measures within the coming 3 months

• Dialysis dependency

• Life expectancy < 12 months

• Insufficient GSM/GPRS-network coverage

• Previously implanted unipolar right atrial lead

• Previously implanted right atrial lead with tip-ring distance > 11 mm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Device:
• Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature)
Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
• Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)
Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)

Locations

Country	Name	City	State
Belgium	A.Z. Middelheim	Antwerpen
Belgium	AZ St. Jan	Brugge
Czech Republic	Nemocnice Ceske Budejovice	Ceske Budejovice
Czech Republic	FN Olomouc	Olomouc
France	Hôpital Gabriel Montpied	Clermont Ferrand
France	CHRU de Lille	Lille
France	CHRU Hôpital de Villeneuve	Montpellier
France	Hôpital Pasteur	Nice
France	Hôpital La Pitié-Salpetrière	Paris
France	CHU Haut Lévêque	Pessac
France	CHU des Rennes, Hôpital de Pontchaillou	Rennes
France	Hôpital Nord	Saint Etienne
France	Centre Hospitalier de Rangueil	Toulouse
Germany	Charitè Berlin	Berlin
Germany	Städtisches Klinikum Dresden-Friedrichstadt	Dresden
Germany	University Hospital	Ulm
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	University Hospital	Groningen
Netherlands	University Medical Center	Leiden
Sweden	Karolinska University Hospital Stockholm	Stockholm
United Kingdom	St. Peter's Hospital	Chertsey

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical composite outcome based on the days lost during 1 year due to: cardiovascular mortality, cardiovascular hospitalization, inappropriate ICD therapy		12 months	No
Secondary	Heart Failure Clinical Composite Score (Packer Score)		12 months	No
Secondary	Reverse remodelling (LA diameter, LVESV, mitral regurgitation)		12 months	No
Secondary	Progression of AF and AT/AF burden		12 months	No