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NCT00355797 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
A Phase 4 study of Bradycardia, sponsored by Biotronik.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,491
- Enrollment target
- 20
- Study locations
NCT00355797 is a Phase 4 study of Bradycardia that has completed, run by Biotronik. The registered enrollment target is 1,491 participants, below the 4,361-participant average among 29 other Bradycardia trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT00355797, a Phase 4 study of Bradycardia, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,491 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DEVICE Closed Loop Stimulation (CLS)
- DEVICE Standard Rate Adaptive (R) Technology
- DEVICE Non-rate adaptive (DDD) pacing
Study Locations (20)
California
- N.R. Devaraj, M.D., Inc. - Anaheim
- Family Doctor Medical Group - Benicia
- Caremore Medical Group - Downey
- Multani Medical Group - Downey
- Solano Cardiology - Fairfield
- Pacific Cardiology Associates - Fremont
- San Joaquin General Hospital - French Camp
- Kenny Charn, MD - Jackson
- Kartik Thaker, MD - Lakewood
- Mission Internal Medical Group - Mission Viejo
- Cardio-Pulmonary Associates - Monterey
- St. Luke Cardiovascular Medical Group - Murrieta
- Sacramento Heart & Vascular - Sacramento
- Emad Khaleeli, MD - Torrance
- Torrance Memorial Medical Center - Torrance
Alabama
- Raymond Fernandez - Albertville
- Cardiology Associates-Gadsden - Gadsden
- North Alabama Cardiology Center - Gadsden
- Richard Kim, MD - Jasper
Arizona
- Arizona Heart Institute - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,491 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00355797
The ClinicalTrials.gov registry entry for NCT00355797 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,491 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,361-participant average among 29 other Bradycardia trials with a reported enrollment target (66% lower). The listed sponsor is Biotronik, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bradycardia appearing as the primary indexed condition, and to 3 interventions - of which Closed Loop Stimulation (CLS) is the first listed.
NCT00355797 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00355797 about?
NCT00355797 is a clinical study titled "Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response". 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 no...
What is the current status of trial NCT00355797?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,491 participants. The study started on 2006-05. Estimated completion is 2010-12.
What conditions does trial NCT00355797 study?
This clinical trial studies the following conditions: Bradycardia.
What interventions are being tested in trial NCT00355797?
The interventions under investigation include: Closed Loop Stimulation (CLS) (DEVICE), Standard Rate Adaptive (R) Technology (DEVICE), Non-rate adaptive (DDD) pacing (DEVICE).
Who is sponsoring clinical trial NCT00355797?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00355797 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.