PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

NCT01672346 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2019-04-10

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • California Pacific Medical Center

    collaborator OTHER
  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale, MD · TCAI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01672346 on ClinicalTrials.gov