Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03115554
• Other study ID #: 16-74
• Status: Terminated
• Phase: N/A
• First received: March 13, 2017
• Last updated: December 13, 2017
• Start date: April 6, 2017
• Est. completion date: August 3, 2017

Study information

• Verified date: December 2017
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(Step 1 - Registration)

• The subject is 18 years of age or older

• Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view

• performed within 6 months)

• Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)

• Provided written informed consent

• Be eligible for an AF ablation procedure for Paroxysmal AF

(Step 2 - Randomization)

• Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation

Exclusion Criteria:

(Step 1 - Registration)

• Pregnant or planning to become pregnant during study

• Co-morbid medical conditions that limit one-year life expectancy

• Previous cardiac surgery

• Patients who have active infection or sepsis

• Patients with esophageal ulcers strictures and varices

• Patients who are contraindicated for anticoagulants such as heparin and warfarin

• Patients who are being treated for ventricular arrhythmias

• Patients who have had a previous left atrial catheter ablation for AF (does not

• include ablation for AFL or other supraventricular arrhythmias)

• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment

• Not competent to legally represent him or herself (e.g., requires a guardian or

• caretaker as a legal representative)

(Step 2 Randomization)

• Not able to receive additional linear or focal intracardiac catheter ablation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVI Plus Catheter Ablation
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
• PVI Alone
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.

Locations

Country	Name	City	State
United States	Aurora Health Care	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence	Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.	12 months
Secondary	Time to recurrence following intervention	Time to recurrence following intervention	12 months post intervention