PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

NCT ID: NCT01672346

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2020-12-31

Brief 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.

Detailed 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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: ACTIVE_COMPARATOR

PVAI followed by adenosine provocation

Intervention Type: PROCEDURE

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).

Arm II

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

Group Type: ACTIVE_COMPARATOR

PVAI followed by adenosine provocation

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Pacific Medical Center

OTHER

Sponsor Role: collaborator

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natale

Executive medical director, TCAI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

TCAI

Locations

St. david's Medical Center

Austin, Texas, United States

Site Status: NOT_YET_RECRUITING

Texas Cardiac arrhythmia Institute, St. David's Hospital

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea Natale, MD

Role: CONTACT

dr.natale@gmail.com

Luigi Di Biase, MD

Role: CONTACT

dibbia@gmail.com

Facility Contacts

Luigi Di Biase, MD PhD

Role: primary

dibbia@gmail.com

Mitra Mohanty, MD

Role: backup

mitra1989@gmail.com

Andrea Natale, MD

Role: primary

dr.natale@gmail.com

512-544-8186

Other Identifiers

ZODIAC_TCAI

Identifier Type: -

Identifier Source: org_study_id