NCT01173809

Brief Summary

This prospective randomized study aims to investigate the effect of continuous versus interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP) atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P25-P50 for phase_3 atrial-fibrillation

Timeline
Completed

Started Oct 2010

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

3.6 years

First QC Date

July 29, 2010

Last Update Submit

August 20, 2014

Conditions

Atrial Fibrillation

Keywords

AFCatheter AblationRecurrence of AFAmiodarone

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial arrhythmia

    Recurrence of AF, atrial flutter or atrial tachycardia

    1 year

Secondary Outcomes (1)

  • Relapse of AF

    1 yeay

Study Arms (2)

Control

ACTIVE COMPARATOR

Patient will continue taking Amiodarone before, during and after catheter ablation (8 weeks post-ablation).

Drug: Amiodarone

Study

ACTIVE COMPARATOR

Amiodarone therapy will be stopped at least 5-months before ablation procedure and ablation will be performed off Amiodarone. Patients will not take Amiodarone during the blanking period (8 weeks post-ablation).

Drug: Amiodarone

Interventions

AmiodaroneDRUG

Patient will continue taking Amiodarone before, during and after ablation (8 weeks post-ablation).

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of LSP AF
  • Age \> 18 years
  • Willing and ability to understand and sign an informed consent
  • Patients on chronic Amiodarone therapy (≥ 3 months)

You may not qualify if:

  • Unstable angina
  • Concomitant treatment with other class I or III antiarrhythmic drugs
  • Myocardial infarction within past 3 months)
  • Presence of any disease that is likely to shorten life expectancy to \< 1 year
  • Symptomatic heart failure, NYHA III or IV
  • Contraindications for Amiodarone
  • Chronic liver diseases
  • Pregnant or breast-feeding mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.David's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (1)

  • Mohanty S, Di Biase L, Mohanty P, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse JG, Horton R, Sanchez JE, Hranitzky PM, Zagrodzky J, Al-Ahmad A, Pelargonio G, Lakkireddy D, Reddy M, Forleo G, Rossillo A, Themistoclakis S, Hongo R, Beheiry S, Casella M, Dello Russo A, Tondo C, Natale A. Effect of periprocedural amiodarone on procedure outcome in patients with longstanding persistent atrial fibrillation undergoing extended pulmonary vein antrum isolation: results from a randomized study (SPECULATE). Heart Rhythm. 2015 Mar;12(3):477-483. doi: 10.1016/j.hrthm.2014.11.016. Epub 2014 Nov 18.

    PMID: 25460855DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Andrea Natale, MD

    TCAI, St.David's Medical Center

    PRINCIPAL INVESTIGATOR

  • Luigi Di Biase, Md, PhD

    Texas Cardiac Arrhythmia Research Foundation

    PRINCIPAL INVESTIGATOR

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
Medical director

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 2, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

US(1)