Status:
UNKNOWN
Rate Adaptive Atrial Pacing in Heart Failure
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
UMC Utrecht
Maasstad Hospital
Conditions:
Chronotropic Incompetence
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 drive...
Eligibility Criteria
Inclusion
- 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
- 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
- Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03235843
Start Date
August 1 2017
End Date
December 1 2019
Last Update
August 2 2017
Active Locations (1)
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1
VU university medical center
Amsterdam, Netherlands, 1081HV