Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT) (effecT)
Primary Purpose
Heart Failure (HF), Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure (HF) focused on measuring CRT, therapy of AF, telecardiology, home monitoring, cardiovascular hospitalization, cardiovascular mortality
Eligibility Criteria
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 (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
Sites / Locations
- A.Z. Middelheim
- AZ St. Jan
- Nemocnice Ceske Budejovice
- FN Olomouc
- Hôpital Gabriel Montpied
- CHRU de Lille
- CHRU Hôpital de Villeneuve
- Hôpital Pasteur
- Hôpital La Pitié-Salpetrière
- CHU Haut Lévêque
- CHU des Rennes, Hôpital de Pontchaillou
- Hôpital Nord
- Centre Hospitalier de Rangueil
- Charitè Berlin
- Städtisches Klinikum Dresden-Friedrichstadt
- University Hospital
- Rijnstate Ziekenhuis
- University Hospital
- University Medical Center
- Karolinska University Hospital Stockholm
- St. Peter's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1: Access to HMSC (Home Monitoring Service Center)
2: No access to HMSC
Arm Description
Full 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
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Heart Failure Clinical Composite Score (Packer Score)
Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.
Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)
Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms
Progression of AF and AT/AF Burden
The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data
Full Information
NCT ID
NCT00811382
First Posted
December 18, 2008
Last Updated
February 2, 2017
Sponsor
Biotronik SE & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00811382
Brief Title
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Acronym
effecT
Official Title
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Criterion according study protocol to end study prematurely was fulfilled.
Study Start Date
May 2008 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure (HF), Atrial Fibrillation
Keywords
CRT, therapy of AF, telecardiology, home monitoring, cardiovascular hospitalization, cardiovascular mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Access to HMSC (Home Monitoring Service Center)
Arm Type
Experimental
Arm Description
Full 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
Arm Title
2: No access to HMSC
Arm Type
Active Comparator
Arm Description
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
Intervention Type
Device
Intervention Name(s)
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)
Intervention Description
Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
Intervention Type
Device
Intervention Name(s)
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Days Lost
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Heart Failure Clinical Composite Score (Packer Score)
Description
Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.
Time Frame
12 months
Title
Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)
Description
Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms
Time Frame
12 months
Title
Progression of AF and AT/AF Burden
Description
The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schalij, Prof. Dr.
Organizational Affiliation
Leiden University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Isabelle Van Gelder, Prof. Dr.
Organizational Affiliation
University of Groningen, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Tijssen, Prof. Dr.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Study Chair
Facility Information:
Facility Name
A.Z. Middelheim
City
Antwerpen
Country
Belgium
Facility Name
AZ St. Jan
City
Brugge
Country
Belgium
Facility Name
Nemocnice Ceske Budejovice
City
Ceske Budejovice
Country
Czech Republic
Facility Name
FN Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Hôpital Gabriel Montpied
City
Clermont Ferrand
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
CHRU Hôpital de Villeneuve
City
Montpellier
Country
France
Facility Name
Hôpital Pasteur
City
Nice
Country
France
Facility Name
Hôpital La Pitié-Salpetrière
City
Paris
Country
France
Facility Name
CHU Haut Lévêque
City
Pessac
Country
France
Facility Name
CHU des Rennes, Hôpital de Pontchaillou
City
Rennes
Country
France
Facility Name
Hôpital Nord
City
Saint Etienne
Country
France
Facility Name
Centre Hospitalier de Rangueil
City
Toulouse
Country
France
Facility Name
Charitè Berlin
City
Berlin
Country
Germany
Facility Name
Städtisches Klinikum Dresden-Friedrichstadt
City
Dresden
Country
Germany
Facility Name
University Hospital
City
Ulm
Country
Germany
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
Country
Netherlands
Facility Name
University Hospital
City
Groningen
Country
Netherlands
Facility Name
University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Karolinska University Hospital Stockholm
City
Stockholm
Country
Sweden
Facility Name
St. Peter's Hospital
City
Chertsey
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
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