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

NCT03115554 | Terminated

• 1 other identifier: 16-74
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Time to recurrence

  Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.

  12 months

Secondary Outcomes (1)

• Time to recurrence following intervention

  12 months post intervention

Study Arms (2)

PVI Plus Catheter Ablation

ACTIVE COMPARATOR

Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.

Procedure: PVI Plus Catheter Ablation

PVI Alone

ACTIVE COMPARATOR

Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.

Procedure: PVI Alone

Interventions

PVI Plus Catheter Ablation PROCEDURE

Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.

PVI Plus Catheter Ablation

PVI Alone PROCEDURE

Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.

PVI Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jasbir Sra, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: April 14, 2017
• Study Start: April 6, 2017
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: October 3, 2024

Record last verified: 2017-12

Locations

US (1)