NCT01546168

Brief Summary

In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

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

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

4.1 years

First QC Date

February 13, 2012

Results QC Date

April 17, 2017

Last Update Submit

January 19, 2018

Conditions

Esophageal DeviationAtrial FibrillationAblation

Keywords

Atrial Fibrillation ablationEsophageal DeviationAF

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Presence of Esophageal Injury

    The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.

    within 1 week of AF ablation procedure

Secondary Outcomes (3)

  • Procedure Time

    day 1, duration ofAF ablation procedure

  • Temperature

    during AF ablation procedure (intraoperative)

  • Swallowing Impairment Score

    during AF ablation procedure (intraoperative)

Study Arms (2)

esophageal deviation

EXPERIMENTAL

esophageal deviation with IDE device during AF ablation

Device: esophageal deviation with IDE device

temperature monitoring

NO INTERVENTION

luminal esophageal temperature monitoring, standard temperature monitoring alone

Interventions

esophageal deviation with IDE deviceDEVICE

esophageal deviation during AF ablation

esophageal deviation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 - Age \< 80 yr
  • Documentation of atrial fibrillation (AF)
  • Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)
  • General anesthesia
  • All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.

You may not qualify if:

  • Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
  • INR \> 4.0 at the time of the procedure
  • H/o of severe esophageal ulcers, strictures, esophagitis or GERD
  • H/o Esophageal Surgery
  • Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)
  • Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
  • Significant abnormality on Swallowing Impairment Score
  • Mental impairment precluding signing consent or completing follow up
  • Patients with any other significant uncontrolled or unstable medical condition
  • Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Florida Hospital

Orlando, Florida, 32803, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78075, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Vivek Y Reddy
Organization
Icahn School of Medicine at Mount Sinai
vivek.reddy@mountsinai.org
212-241-7114

Study Officials

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Cardiac Arrhythmia Service, Professor of Medicine

Study Record Dates

First Submitted

February 13, 2012

First Posted

March 7, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 23, 2018

Results First Posted

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)