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NCT01253200 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
A NA study of Atrial Flutter, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 302
- Enrollment target
- 20
- Study locations
NCT01253200: Completed NA study of Atrial Flutter, sponsored by Boston Scientific Corporation.
NCT01253200 is a NA study of Atrial Flutter that has completed, run by Boston Scientific Corporation. The registered enrollment target is 302 participants, below the 2,110-participant average among 23 other Atrial Flutter trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01253200, a NA study of Atrial Flutter, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 302 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.
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 |
What the finished NCT01253200 record still lists
NCT01253200 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 2,110-participant average among 23 other Atrial Flutter trials with a reported enrollment target (86% lower).
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.
NCT01253200 names 20 study sites across 14 states, led by Ohio, California, Florida.
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.
What interventions are being tested in trial NCT01253200?
The interventions under investigation include: Blazer® Open-Irrigated Ablation Catheter (DEVICE), Control Catheter (DEVICE).
Who is sponsoring clinical trial NCT01253200?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01253200's enrollment target sits among peer trials
302 11th of 23 higher than 13 of 23 other Atrial Flutter trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Flutter 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.
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