PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation (ZODIAC)

Texas Cardiac Arrhythmia Research Foundation

Status and phase: Unknown; Phase 3

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: PVAI followed by adenosine provocation

Study type: Interventional

Funder types: Other

Identifiers

NCT01672346

ZODIAC_TCAI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Arm I

Active Comparator group

Description:

PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge

Treatment:

Procedure: PVAI followed by adenosine provocation

Arm II

Active Comparator group

Description:

AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge

Treatment:

Procedure: PVAI followed by adenosine provocation