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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 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.

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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.

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

FieldValue
Enrollment Target 302 participants
Start Date 2011-01
Est. Completion 2014-01
Phase NA

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT01253200

The ClinicalTrials.gov registry entry for NCT01253200 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,110-participant average among 23 other Atrial Flutter trials with a reported enrollment target (86% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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