Phase 4
N=1,491
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT00355797 ↗Enrolled (actual)
1,491
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Performance of Activities of Daily Living Tests (6-minute Walk and Sweep) — 19.28; 18.09; 18.05 repetitions — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Closed Loop Stimulation (CLS) (Device); Standard Rate Adaptive (R) Technology (Device); Non-rate adaptive (DDD) pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotronik, Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance of Activities of Daily Living Tests (6-minute Walk and Sweep) |
19.28; 18.09; 18.05 | 0.004 sig |
| PRIMARY Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test) |
48.13; 50.00; 50.54 | 0.552 |
| SECONDARY Change in Quality of Life |
-0.41; 0.37; -0.41 | — |
| SECONDARY Mode Reprogramming |
5; 2; 1; 5; 0; 1 | — |
| SECONDARY Atrial Fibrillation (AF) Burden |
7.54; 5.57; 6.65 | — |
| SECONDARY Cardiac Symptoms |
120; 51; 54; 62; 31; 29 | — |
| SECONDARY Change in New York Heart Association (NYHA) Class |
7; 0; 1; 56; 25; 16 | — |
| SECONDARY Change in 6-minute Walk Test Distance |
0.03; 0.41; 0.27 | — |
Summary
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive technology (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).
Eligibility Criteria
Inclusion Criteria
- Implanted within the last 45 days or being considered for implant with a BIOTRONIK pacemaker utilizing CLS rate adaptation technology (currently the Cylos family of pacemakers).
- Ability to give written informed consent
- Geographically stable and able to return for regular follow-ups for 12 months after ADL testing
- At least 18 years old
Exclusion Criteria
- Patients physically limited and unable to perform all or parts of the ADL testing
- Currently enrolled in any other clinical study
- Patients with medical reasons that preclude regular participation in the follow-ups
Data sourced from ClinicalTrials.gov (NCT00355797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.