Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer (RAP)
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|ClinicalTrials.gov Identifier: NCT02003378|
Recruitment Status : Unknown
Verified December 2013 by Sujata S. Balulad, MD, Albany Medical College.
Recruitment status was: Recruiting
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronotropic Incompetence||Device: Pacemaker sensor set to MV Device: Pacemaker sensor set to XL||Not Applicable|
This study is a double-blind, randomized, two-arm (with crossover to other arm) trial that will investigate the benefit of rate responsive pacing with either MV or XL in pacemaker patients that have chronotropic incompetence (CI). Blinding will occur for both the patient and the research personnel who are collecting primary endpoint data. The study will enroll patients that have an implanted dual/single chamber pacemaker, which has both the minute ventilation (MV) and accelerometer (XL) rate-adaptive sensors.
The initial study visit called as baseline visit for newly implanted patients (at 2 weeks from implant) and for previously implanted patients (at the time of enrolling in the study).
Patients will complete a 6-min walk test at the baseline study visit to screen for CI based on the intrinsic heart rate achieved during the walk while pacemaker set to DDD/VVI with both sensors set to passive. All patients that are enrolled in the study will get treadmill exercise stress test by chronotropic assessment exercise protocol (CAEP) to confirm CI. Patients will be determined to have CI by completing a maximal effort exercise treadmill stress test with peak perceived exertion by Borg scale of >16 (18) with the pacemaker programmed to DDD/VVI with both device sensors set to passive. Patients that do not meet the criteria of CI after CAEP treadmill test will not continue in the trial.
Patients that have CI will then be randomized in a 1:1 ratio to programming the rate-adaptive sensor to either MV or XL. The MV or XL rate-adaptive sensor will be optimized for each patient using stress test derived age predicted maximum heart rate by adjusting response factor to achieve MCR slope of 1.
At the 4-week visit, patients that have CI will complete a second CAEP treadmill test in their randomized setting with pacer set as DDDR/VVIR. They will also complete 6-minute walk test and pacemaker interrogation. They will be crossed over to the other sensor group at this time by changing the sensor setting.
At 8 week visit, patients will have another CAEP treadmill test, 6-minute walk test and pacemaker interrogation in their randomized crossed over group setting.
Patients that have CI will get quality of life assessment using SF-36 questionnaire and Aquarel questionnaire at baseline visit, 4 and 8 week visit in their randomized setting.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
Active Comparator: Minute Ventilation (MV)
Pacemaker sensor set to MV (Cross over study)
Device: Pacemaker sensor set to MV
Pacemaker sensor set to minute ventilation
Active Comparator: Accelerometer (XL)
Pacemaker sensor set to XL (Cross over study)
Device: Pacemaker sensor set to XL
Pacemaker sensor set to accelerometer
- Metabolic chronotropic relationship (MCR) slope [ Time Frame: 2 weeks, 6 weeks, and 10 weeks post-implant/post enrollment ]Improvement in functional capacity, determined by MCR slope - if greater using the minute ventilation senor of the accelerometer sensor in patients with chronotropic incompetence
- Changes in heart rate and distance covered during 6-minute walk test [ Time Frame: 2 weeks, 6 and 10 weeks post-implant/post enrollment ]To evaluate the superiority of the minute ventilation sensor or the accelerometer sensor by comparing changes in heart rate and distance covered during activities using a 6 minute walk test.
- Exercise time during chronotropic assessment exercise protocol (CAEP) stress test [ Time Frame: 2 weeks, 6 and 10 weeks post-implant/post enrollment ]To evaluate the superiority of the minute ventilation sensor or the accelerometer sensor related to exercise time during the CAEP stress test
- Quality of life (QOL) assessment [ Time Frame: 2 weeks, 6 and 10 weeks post-implant/post enrollment ]SF-36 questionnaire and Aquarel questionnaire to assess quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003378
|Contact: Wendy Stewart, MSfirstname.lastname@example.org|
|Contact: Sujata Balulad, MDemail@example.com|
|United States, New York|
|Albany Medical College||Recruiting|
|Albany, New York, United States, 12208|
|Contact: Wendy Stewart, MS 518-262-9316 firstname.lastname@example.org|
|Principal Investigator: Sujata Balulad, MD|
|Sub-Investigator: Henry Tan, MD|
|Sub-Investigator: Steven Fein, MD|
|Principal Investigator:||Sujata Balulad, MD||Albany Medical College|