Rate Adaptive Atrial Pacing in Heart Failure (ADAPTION)

Amsterdam UMC, location VUmc

Status: Unknown

Conditions: Chronotropic Incompetence; Heart Failure; ICD

Treatments: Device: DDI-pacing; Device: AAIR pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT03235843

ISROTH20232

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

Rate Adaptive Pacing ON

Active Comparator group

Description:

AAIR pacing using a MV sensor

Treatment:

Device: AAIR pacing

Rate Adaptive Pacing OFF

Placebo Comparator group

Description:

DDI-pacing

Treatment:

Device: DDI-pacing