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Criterion according study protocol to end study prematurely was fulfilled.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Clinical Composite Score (Packer Score) | Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms. | 12 months |
| Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.Z. Middelheim | Antwerp | Belgium | ||||
| AZ St. Jan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Access to HMSC | 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 Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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No Masking.
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|
| 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) |
|
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
| 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 | 12 months |
| 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 |
| FG001 | 2: No Access to 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. Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Access to HMSC | 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. Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring. |
| BG001 | 2: No Access to 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. Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Height,centimeter (cm) | Median | Standard Deviation | cm |
| |||||||||||||||
| Weight, kilogram (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| New York Heart Association functional class (NYHA class) | Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity, but comfortable at rest. Class IV: Unable to carry on any physical activity without discomfort and symptoms of heart failure at rest. This classification is not an outcome but a patient characteristic at enrollment. From the given explanation, it is obvious that lower classes are better. | Count of Participants | Participants |
| |||||||||||||||
| Cardiomyopathy | Number | participants |
| ||||||||||||||||
| Left ventricular ejection fraction (LVEF) | The Left ventricular ejection fraction (EF) is always reported in the unit of percentage (%). It is the ratio of pumped blood volume divided by the maximal filling volume. The EF refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. An EF of 27 percent means that 27 percent of the total amount of blood in the left ventricle is pushed out with each heartbeat. | Median | Standard Deviation | Percentage % |
| ||||||||||||||
| Left Ventricular End-Systolic Volume (LVESV) | Median | Standard Deviation | ml |
| |||||||||||||||
| Left atrial diameter (LAD) | Mean | Standard Deviation | mm |
| |||||||||||||||
| Mitral regurgitation | A definition of the severity of Mitral Regurgitation can not be given, because the study did enforce a specific one and physicians used their standard definitions. It is not possible to describe their meaning for laypersons better that with the term used (mild, moderate, severe) | Count of Participants | Participants |
| |||||||||||||||
| History of VT/VF | Number | patients |
| ||||||||||||||||
| QRS duration | Median | Standard Deviation | ms |
| |||||||||||||||
| Heart Rate | Mean | Standard Deviation | beats/min |
| |||||||||||||||
| AV (atrioventricular) Block | The classification of atrioventricular block as 1st, 2nd and 3rd degree follows the standard textbook definition. It is not possible to describe their meaning for laypersons. This classification is not outcome but a patient characteristic at enrollment. A lower grade is better. | Number | patients |
| |||||||||||||||
| Rhythm at enrollment | Sinus Rhythm: with heart rate in the normal range of 60 - 100 beats/min AF: generally at a rate between 110 and 180 beats/min. | Number | patients |
| |||||||||||||||
| Non-CV (cardiovascular) Morbidity at Enrollment | the sum of participants in all categories for the measure does not equal the overall number of baseline participants due to the fact that patients have sometimes more than 1 non-cv morbidity at enrollment | Number | patients |
| |||||||||||||||
| History of AF | Number | patients |
| ||||||||||||||||
| Ventricular Rate during AF | Mean | Standard Deviation | beats/min |
| |||||||||||||||
| Days since AF is known | Mean | Standard Deviation | days |
| |||||||||||||||
| History of pharmacological cardioversion | Number | patients |
| ||||||||||||||||
| History of electrical cardioversion | Number | patients |
| ||||||||||||||||
| History of atrial ablation | Number | patients |
| ||||||||||||||||
| History AV node ablation | Number | patients |
| ||||||||||||||||
| AF treatment at enrollment | some patients underwent both rate control and rhythm control | Number | patients |
| |||||||||||||||
| Medication at Enrollment | Number | patients |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Days lost per patient | 12 months |
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| Secondary | Heart Failure Clinical Composite Score (Packer Score) | Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms. | Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment | Posted | 12 months |
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| Secondary | 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 | Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment | Posted | 12 months |
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| Secondary | 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 | Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment | Posted | 12 months |
|
From date of randomization until the date of death from any cause, study withdrawal, or study termination, which ever came first, assessed up to 1 year
The definition of Adverse Event (AE) and/or serious AE (SAE), used to collect AE information, differs not from the clinicaltrials.gov definitions. There is no source vocabulary for adverse event terms for this study. It is not possible to provide specific AE Terms (e.g. arrhythmia) to indicate whether or not events were related to the device. We used a standard AE Form to document the relationship to the medical device and the investigator ticked "device related, maybe or not related".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1: Access to HMSC | Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center 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 | 45 | 88 | 6 | 88 | ||
| EG001 | 2: No Access to 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. 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) | 41 | 75 | 8 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device related SAEs | Cardiac disorders | Non-systematic Assessment | It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related". |
| |
| maybe device-related SAEs | Cardiac disorders | Non-systematic Assessment | It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related". |
| |
| not device-related SAEs | Cardiac disorders | Non-systematic Assessment | It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related". |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| device-related AEs | Cardiac disorders | Non-systematic Assessment | It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related". |
| |
| maybe device-related AEs | Cardiac disorders | Non-systematic Assessment | It is not possible to provide specific AE Terms to indicate whether or not AEs were related to the device. We used a standard AE Form to document the relationship to the device and the investigator ticked "device related, maybe or not related". |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mathias Freudigmann | BIOTRONIK | +49(0)30 68905 - 1248 | mathias.freudigmann@biotronik.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Male |
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| Class II |
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| Class III |
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| Class IV |
|
| Non-ischemic |
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| Moderate |
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| Severe |
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| No regurgitation |
|
| not reported |
|
| Patients with No VT/VF |
|
| First Degree |
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| Second Degree |
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| Third Degree |
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| Other |
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| AF |
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| Other |
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| Renal insufficiency |
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| COPD |
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| Thyroid disease |
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| Hepatic disease |
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| Mental disorder |
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| Other |
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| Persistent |
|
| no History of AF |
|
| not successful |
|
| not tried |
|
| not reported |
|
| not successful |
|
| not tried |
|
| not reported |
|
| partly successful |
|
| not successful |
|
| not tried |
|
| not reported |
|
| not successful |
|
| not tried |
|
| not reported |
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| Rhythm control |
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| No AF treatment |
|
| not reported |
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| Amiodarone |
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| Beta blocker |
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| Calcium channel blocker |
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| Digitalis |
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| Sotalol |
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| Other antiarrhythmic |
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| Anticoagulants |
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| Antiplatelet |
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| Lipid-lowering drug |
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| Nitrate |
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| Spironolactone |
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| Other diuretic |
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| Other medication |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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