Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
65 participants
INTERVENTIONAL
2017-08-01
2019-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Rate Adaptive Pacing ON
AAIR pacing using a MV sensor
AAIR pacing
Rate adaptive pacing using a MV sensor.
Rate Adaptive Pacing OFF
DDI-pacing
DDI-pacing
Rate adaptive pacing OFF
Interventions
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AAIR pacing
Rate adaptive pacing using a MV sensor.
DDI-pacing
Rate adaptive pacing OFF
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Maasstad Hospital
OTHER
Northwest Clinics Alkmaar
UNKNOWN
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Cornelis P. Allaart
Principal Investigator
Principal Investigators
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Cornelis P Allaart, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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VU university medical center
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.
Other Identifiers
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ISROTH20232
Identifier Type: -
Identifier Source: org_study_id
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