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Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
NCT01253200 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated Ablation Catheter to outcomes in patients treated with open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter.
Conditions Studied
Interventions
- DEVICE Blazer® Open-Irrigated Ablation Catheter
- DEVICE Control Catheter
Study Locations (20)
Ohio
- Cleveland Clinic Foundation — Cleveland
- Ohio State University Medical Center — Columbus
- Ohio Health Research Institute — Columbus
California
- St. Jude Medical Center — Fullerton
- Regional Cardiology Associates — Sacramento
Florida
- West Coast Arrhythmia Center — Hudson
- Tallahassee Memorial Hospital — Tallahassee
Georgia
- Emory University Hospital — Atlanta
- Georgia Health Sciences University — Augusta
Massachusetts
- Brigham and Women's Hospital — Boston
- Caritas St. Elizabeth's Medical Center — Boston
Alabama
- University of Alabama at Birmingham — Birmingham
Colorado
- Colorado Springs Cardiologist, P.C. — Colorado Springs
District of Columbia
- Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01253200
The ClinicalTrials.gov registry entry for NCT01253200 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atrial Flutter appearing as the primary indexed condition, and to 2 interventions — of which Blazer® Open-Irrigated Ablation Catheter is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01253200 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Ohio, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01253200 about?
NCT01253200 is a clinical study titled "Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter". The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated Ablation Catheter to ...
What is the current status of trial NCT01253200?
This trial is currently completed. It is a NA study. The enrollment target is 302 participants. The study started on 2011-01. Estimated completion is 2014-01.
What conditions does trial NCT01253200 study?
This clinical trial studies the following conditions: Atrial Flutter. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01253200?
The interventions under investigation include: Blazer® Open-Irrigated Ablation Catheter (DEVICE), Control Catheter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01253200?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01253200 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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