APPROPRIATE - Rate Adaptive Pacing Sensor

Condition(s): Heart Diseases
NCTId: NCT00757666

Official Title

Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer

Summary

The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years N/A False

Inclusion Criteria:

- Meets or met current pacemaker implantation indications

- Willing and capable of providing informed consent for participation

- Receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads

- Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment

Exclusion Criteria:

- Mobitz II second degree heart block

- Third degree heart block

- Chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent

- Neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)

- A symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias

- Pulmonary disease as defined by any one of the following:

- Forced Vital Capacity (FVC) or Forced Expiratory Volume in one second (FEV1) < 60% of predicted values

- Use of two or more pulmonary inhalers

- Use of supplemental oxygen

- Chronic use of oral steroids for pulmonary disease treatment

- Life expectancy is less than 12 months due to other medical conditions, per physician discretion

- Has or indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)

- Currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study.

- Younger than 18 years of age

- Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion)

- Unable or unwilling to comply with the protocol requirements

Interventions & Outcomes

Study Interventions & Types

Device Intervention(s)

Rate adaptive pacemaker - Accelerometer sensor
Rate adaptive pacemaker - Minute ventilation sensor

Study Outcomes

Primary Outcome(s)

Timeframe: 1 month and 2 months post-implant
Measure: Improvement in peak VO2.
Safety Issue? No

Secondary Outcome(s)

Measure: Changes in heart rate during Activities of Daily Living (ADL) using a lift and carry test
Timeframe: 2 months post-implant
Safety Issue? No

Measure: Exercise time
Timeframe: 1 month and 2 months post-implant
Safety Issue? No

Measure: Metabolic chronotropic relationship (MCR) slope
Timeframe: 1 month and 2 months post-implant
Safety Issue? No

Measure: VO2 at ventilatory threshold
Timeframe: 1 month and 2 months post-implant
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

Genesis Heart Institute
Davenport, Iowa United States

Cardiology Association of NE Arkansas
Jonesboro, Arkansas United States

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Heart Diseases

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