Chronotropic Incompetence Clinical Trial
— ABSOLVE CIOfficial title:
The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI
Verified date | April 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker sensor which responds only by comparing physical activity, heart rate, and breathing rate; compared to the accelerometer pacemaker sensor which respond only by comparing physical activity and the heart rate in patients whose heart is unable increase its heart rate according to increase physical activity or demand (Chronotropic Incompetence). Only one pacemaker family will be used in this clinical trial whereas the "out of box" configuration is the blended sensor which can also be made to act only as an accelerometer.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 years or older - Evidence of chronotropic incompetence on exercise or pharmacological stress test defined as the inability to achieve 85% or greater of Age-predicted heart rate reserve (APMHR) - Legal status to give informed consent specific to state and national law. - Planned for PPM implantation and meets current guidelines for PPM therapy. Exclusion Criteria: - Inability to give informed consent - Inability to comply with the follow-up visit schedule. - Unable to participate in stress testing (exercise or pharmacological). - Previous PPM implantation - A life expectancy of less than 12 months per physician discretion - Enrolled in any concurrent study, without Boston Scientific written approval. - Pregnancy - Unstable chest pain - Stroke within 30 days - Heart attack within 90 days - Stress Test Exclusion Criteria: No evidence of Chronotropic incompetence on exercise or pharmacological stress test, defined as the ability to achieve 85% or greater of APMHR. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Vivek Reddy | Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changed in Stress Test at 6 Months as Compared to Baseline | An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure. | baseline and 6 months |
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