Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer

NCT02003378 | Unknown

• 1 other identifier: RAP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients' heart rates do not increase as needed during activities and exercise, which can make them feel tired and fatigued easily. The patients in this study have a pacemaker with a FDA approved rate response sensor, which senses activity level by sensing motion (through a component known as an accelerometer) and/or breathing changes (known as minute ventilation). These changes in motion or breathing make the pacemaker increase the patient's heart rate. This study is being conducted to see which rate response sensor is better (motion driven or breathing driven). The study is also investigating whether optimizing the sensor based on the individual patient will give better results in terms of increasing the patient's exercise capacity. The hypothesis is that rate responsive pacing driven by the minute ventilation sensor results in improved functional capacity compared to accelerometer in chronotropically incompetent patients.

Conditions

Chronotropic Incompetence

Keywords

Chronotropic incompetence

Outcome Measures

Primary Outcomes (1)

• Metabolic chronotropic relationship (MCR) slope

  Improvement in functional capacity, determined by MCR slope - if greater using the minute ventilation senor of the accelerometer sensor in patients with chronotropic incompetence

  2 weeks, 6 weeks, and 10 weeks post-implant/post enrollment

Secondary Outcomes (3)

• Changes in heart rate and distance covered during 6-minute walk test

  2 weeks, 6 and 10 weeks post-implant/post enrollment

• Exercise time during chronotropic assessment exercise protocol (CAEP) stress test

  2 weeks, 6 and 10 weeks post-implant/post enrollment

• Quality of life (QOL) assessment

  2 weeks, 6 and 10 weeks post-implant/post enrollment

Study Arms (2)

Minute Ventilation (MV)

ACTIVE COMPARATOR

Pacemaker sensor set to MV (Cross over study)

Device: Pacemaker sensor set to MV

Accelerometer (XL)

ACTIVE COMPARATOR

Pacemaker sensor set to XL (Cross over study)

Device: Pacemaker sensor set to XL

Interventions

Pacemaker sensor set to MV DEVICE

Pacemaker sensor set to minute ventilation

Minute Ventilation (MV)

Pacemaker sensor set to XL DEVICE

Pacemaker sensor set to accelerometer

Accelerometer (XL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of providing informed consent for participation
• Previously received, or previously scheduled to receive, dual-chamber/single chamber pacemaker with active atrial and ventricular leads.Boston Scientific Ingenio K172, K173, K174; or (both Ingenio and Advantio have similar rate response features) Advantio K062, K063, K064 (Boston Scientific CRM, St. Paul, MN).
• 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
• Patients with or without one or more of the following are permitted to enroll:
• Sinus node dysfunction with pacemaker
• Mobitz II second degree heart block or third degree heart block with pacemaker
• Chronic atrial fibrillation and other atrial arrhythmias with controlled heart rate within the past 90 days prior to consent
• Paroxysmal atrial fibrillation on rate controlling medication as long as same rhythm stays throughout the study, sinus or atrial fibrillation.
• Patients with pacemakers requiring beta blocker (or other rate limiting medications) therapy

You may not qualify if:

• Neuromuscular, orthopedic, or vascular disability that prevents normal walking (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, unstable angina or uncontrolled arrhythmias Severe pulmonary disease with inability to exercise
• Severe heart failure with dyspnea at rest and inability to exercise (NYHA class IV) and qualify for the CRT-D
• 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, or within 30 days prior to consent, enrolled in another investigational study that would directly impact the treatment or outcome of the current study.
• Younger than 18 years of age
• Patients with pacemakers of unipolar atrial or ventricular lead configuration
• Patients with abdominal pacemaker implants
• Patients on a ventilator
• Patients with a pacemaker with epicardial lead
• Patients with Pneumothorax, pericardial effusion or pleural effusion
• Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion). Pregnancy test will be done for all female patients of childbearing age before the study, and at each visit.
• Unable or unwilling to comply with the protocol requirements

Sponsors & Collaborators

• Albany Medical College: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

Study Officials

• Sujata Balulad, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Stewart, MS

CONTACT

518-262-9316; stewarw@mail.amc.edu

Sujata Balulad, MD

CONTACT

518-262-5076; balulas@mail.amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

US (1)