Rate Adaptive Atrial Pacing in Heart Failure

Amsterdam UMC, location VUmc65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronotropic Incompetence Heart Failure ICD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS) 2. Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor 3. Symptomatic congestive heart failure (NYHA class II-III) 4. Left ventricular systolic dysfunction (LVEF \<35%) 5. Optimal medical therapy 6. Sinus rhythm 7. Subjects should be able to perform normal daily activities Exclusion Criteria: 1. Age \<18 or incapacitated adult 2. Documented atrial fibrillation in the last 3 months prior to inclusion 3. Indication for pacing (SSS, AV conduction abnormalities requiring pacing) 4. Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator 5. Patients who are unable to tolerate increased pacing rates 6. Indication for cardiac resynchronization therapy Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion