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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborator:
California Pacific Medical Center
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01672346
First received: August 21, 2012
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Procedure: PVAI followed by adenosine provocation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Vein (PV) Reconnection After Pulmonary Vein Antrm Isolation (PVAI) at Different Power Settings and Adenosine Provocation

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • AF recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 188
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge
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).
Other Name: PVAI followed by adenosine provocation
Active Comparator: Arm II
AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge
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).
Other Name: PVAI followed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672346

Contacts
Contact: Andrea Natale, MD dr.natale@gmail.com
Contact: Luigi Di Biase, MD dibbia@gmail.com

Locations
United States, Texas
St. david's Medical Center Not yet recruiting
Austin, Texas, United States, 78705
Contact: Luigi Di Biase, MD PhD       dibbia@gmail.com   
Contact: Mitra Mohanty, MD       mitra1989@gmail.com   
Texas Cardiac arrhythmia Institute, St. David's Hospital Recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale, MD    512-544-8186    dr.natale@gmail.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
California Pacific Medical Center
Investigators
Principal Investigator: Andrea Natale, MD TCAI
  More Information

No publications provided

Responsible Party: Andrea Natale, Executive medical director, TCAI, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01672346     History of Changes
Other Study ID Numbers: ZODIAC_TCAI
Study First Received: August 21, 2012
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
PAF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Adenosine
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014