Study Stopped
Criterion according study protocol to end study prematurely was fulfilled.
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
effecT
1 other identifier
interventional
163
7 countries
21
Brief Summary
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 and AF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
March 23, 2017
CompletedAugust 29, 2024
August 1, 2024
5.7 years
December 18, 2008
December 5, 2016
August 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days Lost
Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.
12 months
Secondary Outcomes (3)
Heart Failure Clinical Composite Score (Packer Score)
12 months
Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)
12 months
Progression of AF and AT/AF Burden
12 months
Study Arms (2)
1: Access to HMSC (Home Monitoring Service Center)
EXPERIMENTALFull functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
2: No access to HMSC
ACTIVE COMPARATORLimited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Interventions
Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via 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)
Eligibility Criteria
You may qualify if:
- Indication for CRT with ICD-backup
- Paroxysmal or persistent AF
- Optimized HF-related medication
You may not qualify if:
- 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 (COPD)
- Planned cardiac surgery or interventional measures within the coming 3 months
- Dialysis dependency
- Life expectancy \< 12 months
- Insufficient GSM (Global System for Mobile Communication)/GPRS (General Packet Radio Service)-network coverage
- Previously implanted unipolar right atrial lead
- Previously implanted right atrial lead with tip-ring distance \> 11 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
A.Z. Middelheim
Antwerp, Belgium
AZ St. Jan
Bruges, Belgium
Nemocnice Ceske Budejovice
České Budějovice, Czechia
FN Olomouc
Olomouc, Czechia
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, France
Charitè Berlin
Berlin, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany
University Hospital
Ulm, Germany
Rijnstate Ziekenhuis
Arnhem, Netherlands
University Hospital
Groningen, Netherlands
University Medical Center
Leiden, Netherlands
Karolinska University Hospital Stockholm
Stockholm, Sweden
St. Peter's Hospital
Chertsey, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the disappointing enrollment speed, it has been decided to discontinue the study. Therefore, the study is not powered to test the planned hypothesis.
Results Point of Contact
- Title
- Mathias Freudigmann
- Organization
- BIOTRONIK
Study Officials
- STUDY CHAIR
Martin Schalij, Prof. Dr.
Leiden University Medical Center
- STUDY CHAIR
Isabelle Van Gelder, Prof. Dr.
University of Groningen, The Netherlands
- STUDY CHAIR
Jan Tijssen, Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No Masking.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 19, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2014
Study Completion
September 1, 2015
Last Updated
August 29, 2024
Results First Posted
March 23, 2017
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share