Rate Adaptive Atrial Pacing in Heart Failure Patients with Chronotropic Incompetence<br>

Completed

Conditions: chronotropic incompetence
inability to increase the heart rate during exercise
10007521

Registration Number: NL-OMON47907

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

- Chronotropic Incompetence
- Implanted with a Boston Scientific dual chamber ICD or CRT-D equipped with
Minute Ventilation sensor
- Symptomatic congestive heart failure (NYHA class II-III)
- Left ventricular systolic dysfunction (Ejection Fraction <40%)
- Optimal (stable) medical therapy
- Sinus rhythm
- Subjects should be able to perform normal daily activities

Exclusion Criteria

- Age <18 or incapacitated adult
- Documented atrial fibrillation >5% per month in the last 3 months prior to
inclusion
- Indication for pacing (Sick Sinus Syndrome, atrioventricular conduction
abnormalities requiring pacing)
- Respiratory rate abnormalities (hyperventilation) or use of a mechanical
ventilator
- Patients who are unable to tolerate increased pacing rates
- Beta-blokker / ivabradine / amiodarone therapy is not an exclusion criterion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is improvement of quality of life in CI heart<br /><br>failure patients. QoL questionnaire score with and without rate adaptive atrial<br /><br>pacing using the MV sensor will be compared. A 10% improvement in QoL score by<br /><br>rate responsive pacing is considered a significant improvement.<br /><br><br /><br>Please refer to chapter 6.1 of the protocol (study parameters/endpoints)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome of the study is:<br /><br>1. Improvement of functional capacity in CI heart failure patients. 6MWT with<br /><br>and without rate adaptive atrial pacing using the MV sensor will be compared. A<br /><br>10% improvement in 6MWT is considered a significant improvement.<br /><br>2. Reversibility of CI by rate adaptive atrial pacing using a MV sensor will be<br /><br>assessed by comparison of the mHRS with and without rate adaptive pacing. The<br /><br>change in mHRS will be correlated to the change in functional capacity,<br /><br>activity level and quality of life.<br /><br>3. Clinical status and daily activity level will be evaluated by assessment of<br /><br>NYHA score and activity score measured by the device*s accelerometer, and will<br /><br>be compared with and without rate adaptive pacing.<br /><br><br /><br>Please refer to chapter 6.1 of the protocol (study parameters/endpoints)</p><br>