Atrial Fibrillation, Heart Failure (HF)
Conditions
Keywords
CRT, therapy of AF, telecardiology, home monitoring, cardiovascular hospitalization, cardiovascular mortality
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.
Interventions
DEVICEHome 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
DEVICEHome 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)
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No Masking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Lost | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Clinical Composite Score (Packer Score) | 12 months | Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms. |
| Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation) | 12 months | 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 | 12 months | 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 |
Countries
Belgium, Czechia, France, Germany, Netherlands, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| 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). | 75 |
| Total | 163 |
Baseline characteristics
| Characteristic | 1: Access to HMSC | Total | 2: No Access to HMSC |
|---|---|---|---|
| AF treatment at enrollment No AF treatment | 21 patients | 38 patients | 17 patients |
| AF treatment at enrollment not reported | 4 patients | 11 patients | 7 patients |
| AF treatment at enrollment Rate control | 16 patients | 30 patients | 14 patients |
| AF treatment at enrollment Rhythm control | 47 patients | 84 patients | 37 patients |
| Age, Continuous | 68.7 years STANDARD_DEVIATION 8.5 | 68.1 years STANDARD_DEVIATION 9.2 | 67.3 years STANDARD_DEVIATION 10 |
| AV (atrioventricular) Block First Degree | 23 patients | 40 patients | 17 patients |
| AV (atrioventricular) Block No relevant finding | 36 patients | 68 patients | 32 patients |
| AV (atrioventricular) Block Other | 18 patients | 37 patients | 19 patients |
| AV (atrioventricular) Block Second Degree | 2 patients | 5 patients | 3 patients |
| AV (atrioventricular) Block Third Degree | 9 patients | 13 patients | 4 patients |
| Body Mass Index (BMI) | 27.6 kg/m^2 STANDARD_DEVIATION 4.4 | 27.6 kg/m^2 STANDARD_DEVIATION 4.4 | 27.6 kg/m^2 STANDARD_DEVIATION 4.4 |
| Cardiomyopathy Ischemic | 49 participants | 89 participants | 40 participants |
| Cardiomyopathy Non-ischemic | 39 participants | 74 participants | 35 participants |
| Days since AF is known | 1222 days STANDARD_DEVIATION 2076 | 974 days STANDARD_DEVIATION 1701 | 644 days STANDARD_DEVIATION 930 |
| Heart Rate | 71 beats/min STANDARD_DEVIATION 14 | 70 beats/min STANDARD_DEVIATION 15 | 68 beats/min STANDARD_DEVIATION 16 |
| Height,centimeter (cm) | 172 cm STANDARD_DEVIATION 9 | 172 cm STANDARD_DEVIATION 9 | 171 cm STANDARD_DEVIATION 8 |
| History AV node ablation not reported | 7 patients | 16 patients | 9 patients |
| History AV node ablation not successful | 1 patients | 1 patients | 0 patients |
| History AV node ablation not tried | 80 patients | 145 patients | 65 patients |
| History AV node ablation successful | 0 patients | 1 patients | 1 patients |
| History of AF no History of AF | 7 patients | 16 patients | 9 patients |
| History of AF Paroxysmal | 60 patients | 107 patients | 47 patients |
| History of AF Persistent | 21 patients | 40 patients | 19 patients |
| History of atrial ablation not reported | 7 patients | 16 patients | 9 patients |
| History of atrial ablation not successful | 3 patients | 4 patients | 1 patients |
| History of atrial ablation not tried | 75 patients | 137 patients | 62 patients |
| History of atrial ablation partly successful | 3 patients | 6 patients | 3 patients |
| History of atrial ablation successful ablation | 0 patients | 0 patients | 0 patients |
| History of electrical cardioversion not reported | 7 patients | 16 patients | 9 patients |
| History of electrical cardioversion not successful | 1 patients | 1 patients | 0 patients |
| History of electrical cardioversion not tried | 50 patients | 92 patients | 42 patients |
| History of electrical cardioversion successful | 30 patients | 54 patients | 24 patients |
| History of pharmacological cardioversion not reported | 7 patients | 16 patients | 9 patients |
| History of pharmacological cardioversion not successful | 5 patients | 8 patients | 3 patients |
| History of pharmacological cardioversion not tried | 61 patients | 115 patients | 54 patients |
| History of pharmacological cardioversion successful | 15 patients | 24 patients | 9 patients |
| History of VT/VF Patients with No VT/VF | 66 patients | 126 patients | 60 patients |
| History of VT/VF Patients with VT/VF | 22 patients | 37 patients | 15 patients |
| Left atrial diameter (LAD) | 49 mm STANDARD_DEVIATION 10 | 48 mm STANDARD_DEVIATION 9 | 48 mm STANDARD_DEVIATION 8 |
| Left ventricular ejection fraction (LVEF) | 27 Percentage % STANDARD_DEVIATION 7 | 27 Percentage % STANDARD_DEVIATION 7 | 26 Percentage % STANDARD_DEVIATION 7 |
| Left Ventricular End-Systolic Volume (LVESV) | 135 ml STANDARD_DEVIATION 58 | 146 ml STANDARD_DEVIATION 64 | 159 ml STANDARD_DEVIATION 70 |
| Medication at Enrollment ACE inhibitor or ARB | 72 patients | 135 patients | 63 patients |
| Medication at Enrollment Amiodarone | 36 patients | 72 patients | 36 patients |
| Medication at Enrollment Anticoagulants | 61 patients | 115 patients | 54 patients |
| Medication at Enrollment Antiplatelet | 39 patients | 64 patients | 25 patients |
| Medication at Enrollment Beta blocker | 69 patients | 132 patients | 63 patients |
| Medication at Enrollment Calcium channel blocker | 5 patients | 8 patients | 3 patients |
| Medication at Enrollment Digitalis | 13 patients | 19 patients | 6 patients |
| Medication at Enrollment Lipid-lowering drug | 63 patients | 110 patients | 47 patients |
| Medication at Enrollment Nitrate | 7 patients | 11 patients | 4 patients |
| Medication at Enrollment Other antiarrhythmic | 1 patients | 2 patients | 1 patients |
| Medication at Enrollment Other diuretic | 72 patients | 135 patients | 63 patients |
| Medication at Enrollment Other medication | 23 patients | 44 patients | 21 patients |
| Medication at Enrollment Sotalol | 5 patients | 7 patients | 2 patients |
| Medication at Enrollment Spironolactone | 42 patients | 70 patients | 28 patients |
| Mitral regurgitation Mild | 38 Participants | 77 Participants | 39 Participants |
| Mitral regurgitation Moderate | 28 Participants | 43 Participants | 15 Participants |
| Mitral regurgitation No regurgitation | 17 Participants | 34 Participants | 17 Participants |
| Mitral regurgitation not reported | 2 Participants | 4 Participants | 2 Participants |
| Mitral regurgitation Severe | 3 Participants | 5 Participants | 2 Participants |
| New York Heart Association functional class (NYHA class) Class I | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association functional class (NYHA class) Class II | 7 Participants | 12 Participants | 5 Participants |
| New York Heart Association functional class (NYHA class) Class III | 75 Participants | 142 Participants | 67 Participants |
| New York Heart Association functional class (NYHA class) Class IV | 6 Participants | 9 Participants | 3 Participants |
| Non-CV (cardiovascular) Morbidity at Enrollment COPD | 18 patients | 31 patients | 13 patients |
| Non-CV (cardiovascular) Morbidity at Enrollment Diabetes mellitus | 35 patients | 55 patients | 20 patients |
| Non-CV (cardiovascular) Morbidity at Enrollment Hepatic disease | 2 patients | 3 patients | 1 patients |
| Non-CV (cardiovascular) Morbidity at Enrollment Mental disorder | 4 patients | 6 patients | 2 patients |
| Non-CV (cardiovascular) Morbidity at Enrollment Other | 28 patients | 47 patients | 19 patients |
| Non-CV (cardiovascular) Morbidity at Enrollment Renal insufficiency | 15 patients | 25 patients | 10 patients |
| Non-CV (cardiovascular) Morbidity at Enrollment Thyroid disease | 15 patients | 24 patients | 9 patients |
| QRS duration | 158 ms STANDARD_DEVIATION 24 | 158 ms STANDARD_DEVIATION 25 | 159 ms STANDARD_DEVIATION 26 |
| Rhythm at enrollment AF | 4 patients | 10 patients | 6 patients |
| Rhythm at enrollment Other | 9 patients | 12 patients | 3 patients |
| Rhythm at enrollment Sinus Rhythm | 75 patients | 141 patients | 66 patients |
| Sex: Female, Male Female | 21 Participants | 37 Participants | 16 Participants |
| Sex: Female, Male Male | 67 Participants | 126 Participants | 59 Participants |
| Ventricular Rate during AF | 104 beats/min STANDARD_DEVIATION 33 | 102 beats/min STANDARD_DEVIATION 33 | 100 beats/min STANDARD_DEVIATION 32 |
| Weight, kilogram (kg) | 82 kg STANDARD_DEVIATION 16 | 81 kg STANDARD_DEVIATION 15 | 81 kg STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 88 | 8 / 75 |
| serious Total, serious adverse events | 45 / 88 | 41 / 75 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1: Access to HMSC | Days Lost | 15.1 Days lost per patient | Standard Deviation 52.5 |
| 2: No Access to HMSC | Days Lost | 16.0 Days lost per patient | Standard Deviation 47.8 |
p-value: 0.97Wilcoxon (Mann-Whitney)
Secondary
Heart Failure Clinical Composite Score (Packer Score)
Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.
Time frame: 12 months
Population: Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment
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
Time frame: 12 months
Population: Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment
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
Time frame: 12 months
Population: Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment