Recruiting

Minute Ventilation vs. Accelerometer

Sponsor:

Albany Medical College

Code:

NCT02003378

Conditions

Chronotropic Incompetence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pacemaker sensor set to MV

Pacemaker sensor set to XL

Study Details

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

Study ID

NCT02003378

Start date

Sep, 2013

Status verified date

Dec, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Minute Ventilation (MV)

Pacemaker sensor set to MV (Cross over study)

active comparator: Accelerometer (XL)

Pacemaker sensor set to XL (Cross over study)

Interventions

Pacemaker sensor set to MV

Pacemaker sensor set to minute ventilation

Pacemaker sensor set to XL

Pacemaker sensor set to accelerometer

Primary outcome measure

  • Metabolic chronotropic relationship (MCR) slope [ Time Frame: 2 weeks, 6 weeks, and 10 weeks post-implant/post enrollment ]

Central Contacts and Locations

Central contacts

Wendy Stewart, MS

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

Sujata Balulad, MD

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

Locations

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Contacts

Wendy Stewart, MS

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

Principal Investigator:

Sujata Balulad, MD

More Information

Sponsor

Albany Medical College

Last update posted

Dec 6, 2013

Last verified

Dec, 2013

Keywords

  • Chronotropic incompetence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2013-12-06.