Second Study to Assess Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Long Standing Persistent Atrial Fibrillation

NCT02019238 | Terminated DMC

• 1 other identifier: 818358
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources should be more efficacious than PVI combined with ablation of only documented non-PV triggers of AF in achieving long-term arrhythmia control in patients with persistent or long standing persistent AF.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary

  Compare PVI strategies in group 1 (documented non-PV triggers of AF) to group 2 (PVI combined with empiric ablation of common sites) over 12 months to assess for recurrence of atrial fibrillation.

  1 year

Study Arms (2)

Group 1-Standard PVI ablation

PLACEBO COMPARATOR

Pulmonary Vein Isolation procedure combined with ablation of documented non-PV triggers of AF

Other: Pulmonary Vein Isolation procedure

Group 2-PVI with empiric ablation

ACTIVE COMPARATOR

Pulmonary Vein Isolation procedure combined with empiric ablation of common sites of non-PV triggers of AF and locations that may sustain AF sources on long term arrhythmia control

Other: Pulmonary Vein Isolation procedure

Interventions

Pulmonary Vein Isolation procedure OTHER

comparing the efficacy of PVI ablation vs PVI combined with empiric ablation

Also known as: PVI ablation procedure

Group 1-Standard PVI ablation; Group 2-PVI with empiric ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients of age ≥ 18 years, undergoing their first ablation procedure that meet American College of Cardiology / American Heart Association defined criteria for persistent or long standing persistent AF will be eligible to participate in the proposed study. This includes patients with a history of AF episodes lasting at least 7 days and requiring at least 2 cardioversions.

You may not qualify if:

• Patients with paroxysmal AF (self-terminating episodes lasting \< 7 day)
• Patients who have had a previous AF ablation procedure
• Failure to obtain informed consent
• Patients \< 18 years of age. Investigators will plan to exclude paroxysmal AF patients and concentrate on patients with persistent or long standing persistent AF who may require further ablation to achieve better outcomes. Patients who have undergone previous AF ablation procedure will be excluded since the prior methodology used may confound the results of this study.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Sanjay Dixit, MD

  University of Pensylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 24, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (1)