NCT01710150

Brief Summary

The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

October 11, 2012

Last Update Submit

April 28, 2017

Conditions

Typical Atrial FlutterRisk Factors With Future Development of Atrial Flutter

Keywords

typical aflutter (AFLT)CTI ablationAtrial Fibrillation (AF)PVI

Outcome Measures

Primary Outcomes (1)

  • Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).

    2 years

Secondary Outcomes (1)

  • Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death

    2 years

Other Outcomes (1)

  • Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation.

    2 years

Study Arms (2)

CTI ablation only

PLACEBO COMPARATOR

subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter

Procedure: CTI ablation alone

CTI ablation and PVI.

ACTIVE COMPARATOR

subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.

Procedure: CTI ablation and Pulmonary vein isolation (PVI)

Interventions

CTI ablation alonePROCEDURE
CTI ablation only
CTI ablation and Pulmonary vein isolation (PVI)PROCEDURE
CTI ablation and PVI.

Eligibility Criteria

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

You may qualify if:

  • All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.
  • Risk factors for predicting future occurrence of AF will include:
  • prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
  • LA size \> 4.0 cm,
  • left ventricular ejection fraction (LVEF) ≤ 50%,
  • hypertension, and/or 5) obstructive sleep apnea.

You may not qualify if:

  • Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
  • inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
  • failure to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Mohanty S, Natale A, Mohanty P, DI Biase L, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Hao S, Hongo R, Beheiry S, Pelargonio G, Forleo G, Rossillo A, Themistoclakis S, Casella M, Russo AD, Tondo C, Dixit S. Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF). J Cardiovasc Electrophysiol. 2015 Aug;26(8):819-825. doi: 10.1111/jce.12688. Epub 2015 May 26.

    PMID: 25884325DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sanjay Dixit, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 18, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)