Rate Adaptive Atrial Pacing in Heart Failure

Not Applicable

• Conditions: ICD; Chronotropic Incompetence; Heart Failure
• Interventions: Device: DDI-pacing; Device: AAIR pacing

• Registration Number: NCT03235843
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-27
• Status Verified: 2017-08
• Study Start: 2017-08-01
• Study First Posted: 2017-08-01
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rate Adaptive Pacing OFF	DDI-pacing	DDI-pacing
Rate Adaptive Pacing ON	AAIR pacing	AAIR pacing using a MV sensor

Primary Outcome Measures

Name	Time	Method
Improvement of quality of life	3 months after changing the pacing mode	Measured with the Minnesota Living with Heart Failure Questionnaire

Secondary Outcome Measures

Name	Time	Method
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.
Improvement of functional capacity	3 months after changing the pacing mode	Measured with a six-minute walk test
Daily activity level	3 months after changing the pacing mode	Measured with the device's accelerometer

Trial Locations

Locations (1)

VU university medical center; 🇳🇱 Amsterdam, Netherlands