Atrial Fibrillation Recurrence After Cryoballoon Ablation

Atrial Fibrillation Clinical Trial

Official title:

Mechanisms and Patterns of Atrial Fibrillation Recurrence After Cryoballoon Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772030
• Other study ID #: PRO12060524
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 7, 2019

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation

• At least 18 years old

• Able to read and understand informed consent

Exclusion Criteria:

• Unable to give informed consent

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Other:
• Use of the Achieve catheter followed by ICE-guided mapping catheter

Locations

Country	Name	City	State
United States	UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of pulmonary vein isolation or reconnection		During repeat cryoballoon ablation procedure