NCT00434694

Brief Summary

This is a study of different techniques for treatment of atrial fibrillation using a procedure called radiofrequency catheter ablation. Atrial fibrillation (called AF) is when the upper chambers of the heart (the atria) beat much faster than the lower chambers, causing the heart to beat less effectively. AF can cause stroke, impaired performance, palpitations, shortness of breath, passing out and other symptoms. Radiofrequency ablation involves placement of catheter/electrode wires into the heart through plastic tubes inserted into veins / arteries in both the groins and the right side of the neck under local anesthesia. Radiofrequency energy is delivered to the areas inside the heart that cause the rapid firing of the atria, causing small lesions or "burns" that destroy the heart tissue where the extra electrical impulses come from. Commonly this area is where the four pulmonary veins (PV) deliver blood from the lungs to the left side of the heart, and the procedure is also referred to as "pulmonary vein isolation" or PVI. This study compares two different strategies for performing the pulmonary vein isolation procedure, and compares the effect using two different types of radiofrequency ablation catheters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

2.6 years

First QC Date

February 12, 2007

Last Update Submit

November 24, 2015

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCatheter ablationPulmonary Vein

Outcome Measures

Primary Outcomes (1)

  • Long-term control of AF (defined as complete freedom and/or >90% reduction in AF burden) either off or on previously ineffective antiarrhythmic drugs (AAD) at 1 year after a single ablation procedure.

Secondary Outcomes (4)

  • Efficacy of either strategy in achieving freedom from AF off AAD at 1 year after a single ablation procedure

  • Total procedure time

  • Total fluoroscopy time

  • Serious cardiac adverse events, including: cerebrovascular events, pericardial effusion resulting in tamponade, significant PV stenosis, left atrial-esophageal fistula and death.

Interventions

Pulmonary Vein Isolation (Radiofrequency Catheter Ablation)PROCEDURE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All pts of age 40 years or over that are referred to our center for ablation of AF and meet the clinical criteria to undergo the procedure shall be eligible to participate in the study.

You may not qualify if:

  • Failure to obtain informed consent
  • Age \< 40 years
  • Despite the reported low incidence of pulmonic vein stenosis (0.8%) as a potential complication of PV isolation in pts undergoing AF ablation, in younger pts where it appears that AF results mostly from foci from a limited number of PVs, we feel that including them in the current study with a possibility of having all 4 PVs isolated cannot be justified.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Sanjay Dixit, MD

    University of Pennsylvania

    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

February 12, 2007

First Posted

February 13, 2007

Study Start

July 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations

US(2)