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Rate Adaptive Atrial Pacing in Heart Failure (ADAPTION)

A

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

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

Trial contacts and locations

1

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Central trial contact

Cornelis P Allaart, MD, PhD; Anne-Lotte CJ van der Lingen, MD

Data sourced from clinicaltrials.gov

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