Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Bradycardia, sponsored by Biotronik.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Six-minute walk test and sweep test results for subjects completing tests in all three pacing modes and requiring at least 80% pacing during both tests in the CLS and R pacing modes. The mean composite of repetitions (six minute walk plus sweep) are presented.
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 |
What the finished NCT00355797 record still lists
NCT00355797 is an interventional study that assigns participants to a tested intervention. Its 1,491 participants enrollment target places it among the larger protocols in the corpus, below the 4,361-participant average among 29 other Bradycardia trials with a reported enrollment target (66% lower).
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
Similar trials for Bradycardia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00355797's enrollment target sits among peer trials
1,491 11th of 29 higher than 19 of 29 other Bradycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bradycardia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
ULTRA Study for Pacemaker Patients
COMPLETED · Phase 4
-
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
RECRUITING · NA
-
Aveir VR Real-World Evidence Post-Approval Study
RECRUITING
-
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
RECRUITING
-
The Alaska Oculocardiac Reflex Study
RECRUITING
-
His Bundle Pacing in Bradycardia and Heart Failure
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05869552 · 1,485 participants · NA
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care
- NCT00178724 · 1,500 participants
Spinal Cord Injury Registry - North American Clinical Trials Network
- NCT00951366 · 1,500 participants
Preterm Lung Patient Registry
- NCT01050504 · 1,500 participants
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia