Heart Failure (HF)effecTNCT00811382
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
A study testing Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature) and Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring) in people with Heart Failure (HF) and Atrial Fibrillation, run by Biotronik SE & Co. KG at 21 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure (HF), Atrial Fibrillation
- What is being tested?
- Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature) and Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 21 sitesin 7 countries
- Study dates
- May 2008to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for CRT with ICD-backup
- Paroxysmal or persistent AF
- Optimized HF-related medication
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
France9 sites
Hôpital Gabriel Montpied
Clermont-Ferrand
CHRU de Lille
Lille
CHRU Hôpital de Villeneuve
Montpellier
Hôpital Pasteur
Nice
Hôpital La Pitié-Salpetrière
Paris
CHU Haut Lévêque
Pessac
CHU des Rennes, Hôpital de Pontchaillou
Rennes
Hôpital Nord
Saint-Etienne
Centre Hospitalier de Rangueil
Toulouse
Germany3 sites
Charitè Berlin
Berlin
Städtisches Klinikum Dresden-Friedrichstadt
Dresden
University Hospital
Ulm
Netherlands3 sites
Rijnstate Ziekenhuis
Arnhem
University Hospital
Groningen
University Medical Center
Leiden
About this study
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.
Read the 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.
- Conditions
- Heart Failure (HF), Atrial Fibrillation
- Being tested
- 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)
- Keywords
- CRT, therapy of AF, telecardiology, home monitoring, cardiovascular hospitalization, cardiovascular mortality
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)Device
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)Device
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)
| Study group | Role | What they receive |
|---|---|---|
| 1: Access to HMSC (Home Monitoring Service Center) | Experimental | 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 Receives: Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature) |
| 2: No access to HMSC | Active comparator | 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. Receives: Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Heart Failure Clinical Composite Score (Packer Score)
Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2014
- Study completionSep 2015
Why it stopped: Criterion according study protocol to end study prematurely was fulfilled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Schalij, Prof. Dr., Study chair, Leiden University Medical CenterIsabelle Van Gelder, Prof. Dr., Study chair, University of Groningen, The NetherlandsJan Tijssen, Prof. Dr., Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811382
- Sponsor's protocol ID
- HS044
- Acronym
- effecT
- Status last verified
- Aug 2024
- First submitted
- 18 Dec 2008
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
- ClinicalTrials.gov ID
- NCT00811382
- Acronym / sponsor ID
- effecT / HS044
- Conditions
- Heart Failure (HF), Atrial Fibrillation
- Keywords
- CRT, therapy of AF, telecardiology, home monitoring, cardiovascular hospitalization, cardiovascular mortality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Criterion according study protocol to end study prematurely was fulfilled.
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- May 2008 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Access to HMSC (Home Monitoring Service Center) | Experimental | Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)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 |
| 2: No access to HMSC | Active comparator | Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for CRT with ICD-backup
- Paroxysmal or persistent AF
- Optimized HF-related medication
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | 1: Access to HMSC (Home Monitoring Service Center) |
| 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) | Device | 2: No access to HMSC |
Primary outcome
Days Lost
Time frame: 12 months
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.
3 secondary outcomes
Heart Failure Clinical Composite Score (Packer Score)
Time frame: 12 months
Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)
Time frame: 12 months
Progression of AF and AT/AF Burden
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schalij, Prof. Dr. study chair
Leiden University Medical Center
Isabelle Van Gelder, Prof. Dr. study chair
University of Groningen, The Netherlands
Jan Tijssen, Prof. Dr. study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature) and Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring) in people with Heart Failure (HF) and Atrial Fibrillation, run by Biotronik SE & Co. KG at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Germany, Netherlands, Belgium, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days Lost (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.