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Rate Adaptive Atrial Pacing in Heart Failure

NCT03235843 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-08-02

No results posted yet for this study

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

Interventions

DEVICE

AAIR pacing

Rate adaptive pacing using a MV sensor.

DEVICE

DDI-pacing

Rate adaptive pacing OFF

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Maasstad Hospital

    collaborator OTHER

  • Northwest Clinics Alkmaar

    collaborator UNKNOWN

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Cornelis P Allaart, MD, PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-08-01
Completion
2019-12-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03235843 on ClinicalTrials.gov