PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

NCT01672346 | Unknown Phase 3

• 1 other identifier: ZODIAC_TCAI
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

PAF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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

Arm II

ACTIVE COMPARATOR

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

Interventions

PVAI followed by adenosine provocation 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 I; Arm II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients presenting with drug-refractory PAF undergoing first ablation
• Ability to understand and provide signed informed consent

You may not qualify if:

• Previous catheter ablation or MAZE procedure in left atrium
• Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead
• California Pacific Medical Center: collaborator

Study Sites (2)

St. david's Medical Center

Austin, Texas, 78705, United States

NOT YET RECRUITING

Texas Cardiac arrhythmia Institute, St. David's Hospital

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Natale, MD

  TCAI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Natale, MD

CONTACT

dr.natale@gmail.com

Luigi Di Biase, MD

CONTACT

dibbia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive medical director, TCAI

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: May 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (2)