APPROPRIATE - Rate Adaptive Pacing Sensor

Heart Diseases Clinical Trial

— APPROPRIATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00757666
• Other study ID #: CR-CA-082808-B
• Status: Terminated
• Phase: Phase 4
• First received: September 19, 2008
• Last updated: February 23, 2011
• Start date: October 2008
• Est. completion date: August 2012

Study information

• Verified date: February 2011
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• Rate adaptive pacemaker
Accelerometer sensor
• Rate adaptive pacemaker
Minute ventilation sensor

Locations

Country	Name	City	State
United States	Genesis Heart Institute	Davenport	Iowa
United States	Cardiology Association of NE Arkansas	Jonesboro	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in peak VO2.		1 month and 2 months post-implant	No
Secondary	Changes in heart rate during Activities of Daily Living (ADL) using a lift and carry test		2 months post-implant	No
Secondary	Metabolic chronotropic relationship (MCR) slope		1 month and 2 months post-implant	No
Secondary	Exercise time		1 month and 2 months post-implant	No
Secondary	VO2 at ventilatory threshold		1 month and 2 months post-implant	No