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NCT00113178 Clinical Trial

Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter

Atrial Flutter Clinical Trial

Official title:
Clinical Study to Evaluate the Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Cavo-Tricuspid Valve Isthmus-Dependent Atrial Flutter

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00113178
Other study ID # GL-AFL-02
Secondary ID
Status Completed
Phase Phase 3
First received June 6, 2005
Last updated February 23, 2011
Start date January 2004
Est. completion date June 2005

Study information
Verified date February 2011
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.

Description:

Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Symptomatic atrial flutter

Exclusion Criteria:

- Prior ablation

- Contraindication to intervention

- Poor general health

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Catheter-based cardiac cryoablation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary Acute efficacy
Primary Acute safety
Secondary Long-term efficacy
Secondary Long-term safety
See also
  Status Clinical Trial Phase
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Terminated NCT02317029 - Comparison of Oxygen Interventions and Defibrillator Efficiency N/A
Recruiting NCT01563848 - Cryoablation in Patients With Atrial Flutter Phase 2
Completed NCT01229254 - Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter Phase 2
Completed NCT00839657 - Clarification of Optimal Anticoagulation Through Genetics Phase 3
Completed NCT02065388 - Pharmacogenetic Dosing of Warfarin Phase 3
Completed NCT00232232 - Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT05468281 - RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter
Completed NCT03627143 - Decreasing Hospital Admissions From the ED for AAFF N/A
Completed NCT02917538 - A Randomized Trial of Contact Force in Atrial Flutter Ablation N/A
Enrolling by invitation NCT05903313 - A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Recruiting NCT05755074 - Ablation of Typical Right Atrial Flutter N/A
Recruiting NCT05883631 - RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. N/A
Recruiting NCT03272620 - Atrial Fibrillation at the Viennese University Emergency Department N/A
Completed NCT02810938 - MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology
Recruiting NCT02591875 - Atrial Flutter Ablation in a Real World Population N/A
Completed NCT02268799 - High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter N/A
Completed NCT01914497 - Dipole Density Mapping of Typical Atrial Flutter N/A
Active, not recruiting NCT01976507 - Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism Phase 4

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