PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

Paroxysmal Atrial Fibrillation Clinical Trial

— ZODIAC  

Official title:

Pulmonary Vein (PV) Reconnection After Pulmonary Vein Antrm Isolation (PVAI) at Different Power Settings and Adenosine Provocation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01672346
• Other study ID #: ZODIAC_TCAI
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2013
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Andrea Natale, MD
• Email: dr.natale[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this prospective randomized study, we aim to compare the rate of PV reconnection following PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV conduction will be unmasked by adenosine-provocation.

Description:

Background:

The efficiency of catheter ablation in drug-refractory atrial fibrillation (AF) is compromised by high incidence of post-ablation AF recurrences requiring multiple ablation procedures (1). Post-PVAI (pulmonary vein antrum isolation) AF recurrence is mostly due to reconnection of the previously isolated PVs (2). Earlier studies have revealed that elimination of dormant PV conduction revealed by adenosine-provocation ensures better outcome as reconnection mostly happens due to presence of incompletely ablated tissue and identification and complete ablation decrease chance of recurrence (1). Adenosine is specifically chosen for induction of triggers because it is known to transiently or permanently re-establish left atrium-pulmonary vein (LA-PV) conduction after apparently successful PV isolation (3). Datino et al have demonstrated in the canines that adenosine selectively hyperpolarizes the PVs by increasing inward rectifier potassium (K+) current and restores excitability (4). As incompletely ablated tissue can potentially cause AF recurrence, the depth and extension of the lesion are crucial factors in determining the success-rate of ablation; these in turn are directly influenced by catheter type and the radio-frequency (RF) energy settings (5). In a previous study, Matiello et al have reported cooled-tip catheter at 40w setting to be more effective in preventing recurrence than that with 30w setting (5). However, none of the earlier studies have examined the rate of PV reconnection when AF ablation is done at different power settings using open-irrigated catheters after the dormant sites are revealed by adenosine-challenge.

Hypothesis:

Use of higher wattage during ablation before and after adenosine-challenge is associated with lower rate of PV reconnection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Patients presenting with drug-refractory PAF undergoing first ablation

3. Ability to understand and provide signed informed consent

Exclusion Criteria:

1. Previous catheter ablation or MAZE procedure in left atrium

2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• PVAI followed by adenosine provocation
All patients will undergo PVAI and ablation of the posterior wall of the LA using an open-irrigated ablation catheter and under general anesthesia. After PV isolation is achieved, all will undergo PVAI followed by adenosine provocation test with 24 mg of adenosine to check for PV reconnection. Upon identification, additional RF energy would be used to ablate those sites (that were revealed by adenosine-provocation).

Locations

Country	Name	City	State
United States	St. david's Medical Center	Austin	Texas
United States	Texas Cardiac arrhythmia Institute, St. David's Hospital	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation	California Pacific Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence	Recurrence of AF due to PV reconnection AF recurrence is defined as any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence. Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.	1 year