Rate Adaptive Atrial Pacing in Heart Failure

Study Overview
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Brief Summary
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The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting. Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence. Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.

Official Title
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Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence

Conditions
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ICD, Chronotropic Incompetence, Heart Failure

Intervention / Treatment
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* Device: AAIR pacing
* Device: DDI-pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS) Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor Symptomatic congestive heart failure (NYHA class II-III) Left ventricular systolic dysfunction (LVEF <35%) Optimal medical therapy Sinus rhythm Subjects should be able to perform normal daily activities Exclusion Criteria: Age <18 or incapacitated adult Documented atrial fibrillation in the last 3 months prior to inclusion Indication for pacing (SSS, AV conduction abnormalities requiring pacing) Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator Patients who are unable to tolerate increased pacing rates Indication for cardiac resynchronization therapy Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rate Adaptive Pacing ON<br>AAIR pacing using a MV sensor | Device: AAIR pacing<br>* Rate adaptive pacing using a MV sensor.<br>|
| Placebo Comparator: Rate Adaptive Pacing OFF<br>DDI-pacing | Device: DDI-pacing<br>* Rate adaptive pacing OFF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life | Measured with the Minnesota Living with Heart Failure Questionnaire | 3 months after changing the pacing mode | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of functional capacity | Measured with a six-minute walk test | 3 months after changing the pacing mode | 
| Reversibility of chronotropic incompetence | A comparison of the modified HeartRateScore with and without rate adaptive pacing. | 3 months after changing the pacing mode | 
| Clinical status | Measured with NYHA class assessment and number of hospitalizations for heart failure. | 3 months after changing the pacing mode | 
| Daily activity level | Measured with the device's accelerometer | 3 months after changing the pacing mode | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Chronotropic Incompetence, Rate Adaptive Pacing, Minute Ventilation Sensor, Primary Prevention ICD Therapy, Implantable Cardioverter Defibrillator, Exercise Intolerance