Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

NCT01590875 | Completed Results

• 1 other identifier: MCWPRO00016186
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ablation; pulmonary veins; adenosine

Outcome Measures

Primary Outcomes (2)

• Pulmonary Vein Reconnection

  In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes after adenosine administration.

  5 minutes post infusion first dose adenosine

• Pulmonary Vein Reconnection

  In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein. Pulmonary vein isolation is defined as disappearance of all local intracardiac electrograms within a pulmonary vein recorded on a 10 electrode circular catheter or lasso catheter positioned within the vein.

  Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.

Study Arms (2)

Adenosine arm

EXPERIMENTAL

25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.

Drug: Adenosine arm

Observation arm

NO INTERVENTION

25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.

Interventions

Adenosine arm DRUG

In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.

Adenosine arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications

You may not qualify if:

• allergy or contraindication to adenosine,
• inability to give informed consent,
• currently taking dipyridamole,
• verapamil or theophylline and
• breast-feeding mothers.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Marcie Berger, MD
• Organization: Medical College of Wisconsin

mgberger@mcw.edu

414-955-6806

Study Officials

• Marcie G Berger, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 3, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 6, 2017
• Results First Posted: May 3, 2017

Record last verified: 2017-10

Locations

US (1)