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

Heart Failure Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT00811382
• Study type: Interventional
• Source: Biotronik SE & Co. KG
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Completion date: September 2015