Rate Adaptive Atrial Pacing in Heart Failure

Heart Failure Clinical Trial

— ADAPTION  

Official title:

Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235843
• Other study ID #: ISROTH20232
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: August 1, 2017
• Start date: August 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2017
• Source: VU University Medical Center
• Contact: Cornelis P Allaart, MD, PhD
• Phone: +31 (0)20 4445043
• Email: cp.allaart[@]vumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronotropic Incompetence
• Heart Failure
• ICD

Intervention

Device:
• AAIR pacing
Rate adaptive pacing using a MV sensor.
• DDI-pacing
Rate adaptive pacing OFF

Locations

Country	Name	City	State
Netherlands	VU university medical center	Amsterdam

Sponsors (4)

Lead Sponsor	Collaborator
VU University Medical Center	Maasstad Hospital, Northwest Clinics Alkmaar, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of quality of life	Measured with the Minnesota Living with Heart Failure Questionnaire	3 months after changing the pacing mode
Secondary	Improvement of functional capacity	Measured with a six-minute walk test	3 months after changing the pacing mode
Secondary	Reversibility of chronotropic incompetence	A comparison of the modified HeartRateScore with and without rate adaptive pacing.	3 months after changing the pacing mode
Secondary	Clinical status	Measured with NYHA class assessment and number of hospitalizations for heart failure.	3 months after changing the pacing mode
Secondary	Daily activity level	Measured with the device's accelerometer	3 months after changing the pacing mode