ADAPTION: Rate Adaptive Atrial Pacing in Heart Failure

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Unknown status

CT.gov ID

NCT03235843

Collaborator

UMC Utrecht (Other), Maasstad Hospital (Other), Northwest Clinics Alkmaar (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronotropic Incompetence Heart Failure ICD	Device: AAIR pacing Device: DDI-pacing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.

Masking:

Double (Participant, Investigator)

Masking Description:

The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.

Primary Purpose:

Treatment

Official Title:

Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence

Actual Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rate Adaptive Pacing ON AAIR pacing using a MV sensor	Device: AAIR pacing Rate adaptive pacing using a MV sensor.
Placebo Comparator: Rate Adaptive Pacing OFF DDI-pacing	Device: DDI-pacing Rate adaptive pacing OFF

Arm

Intervention/Treatment

Active Comparator: Rate Adaptive Pacing ON

AAIR pacing using a MV sensor

Device: AAIR pacing

Rate adaptive pacing using a MV sensor.

Placebo Comparator: Rate Adaptive Pacing OFF

DDI-pacing

Device: DDI-pacing

Rate adaptive pacing OFF

Outcome Measures

Primary Outcome Measures

Improvement of quality of life [3 months after changing the pacing mode]
Measured with the Minnesota Living with Heart Failure Questionnaire

Secondary Outcome Measures

Improvement of functional capacity [3 months after changing the pacing mode]
Measured with a six-minute walk test
Reversibility of chronotropic incompetence [3 months after changing the pacing mode]
A comparison of the modified HeartRateScore with and without rate adaptive pacing.
Clinical status [3 months after changing the pacing mode]
Measured with NYHA class assessment and number of hospitalizations for heart failure.
Daily activity level [3 months after changing the pacing mode]
Measured with the device's accelerometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
Symptomatic congestive heart failure (NYHA class II-III)
Left ventricular systolic dysfunction (LVEF <35%)
Optimal medical therapy
Sinus rhythm
Subjects should be able to perform normal daily activities

Exclusion Criteria:

Age <18 or incapacitated adult
Documented atrial fibrillation in the last 3 months prior to inclusion
Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
Patients who are unable to tolerate increased pacing rates
Indication for cardiac resynchronization therapy