NCT03235843

Rate Adaptive Atrial Pacing in Heart Failure

Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronotropic Incompetence
• Heart Failure
• ICD

Interventions

Type	Name	Description
DEVICE	AAIR pacing	Rate adaptive pacing using a MV sensor.
DEVICE	DDI-pacing	Rate adaptive pacing OFF

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-08-01
• Completion: 2019-12-01
• First posted: 2017-08-01
• Last updated: 2017-08-02

Locations

1 site across 1 country: Netherlands