NCT03082963

Brief Summary

The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF. The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable 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

February 27, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

5.2 years

First QC Date

February 27, 2017

Results QC Date

June 13, 2023

Last Update Submit

July 17, 2023

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationablation

Outcome Measures

Primary Outcomes (1)

  • Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility

    As measured by number of patients where real-time EMR mapping is completed.

    2 hours

Secondary Outcomes (3)

  • Ablation Acute Effects

    2 hours

  • Number of Participants With Treatment Emergent Adverse Events

    30 days

  • Ablation Acute Effects

    2 hours

Study Arms (1)

EMR Feasibility

OTHER

In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.

Device: Electrogram Morphology Mapping (EMR)

Interventions

Electrogram Morphology Mapping (EMR)DEVICE

Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium \& then the left atrium.

EMR Feasibility

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female at least 21 years of age
  • persistent Afib with one prior failed ablation for persistent or long standing persistent Afib

You may not qualify if:

  • Inability to sign consent
  • Patients with a life expectancy less than one (1) year
  • Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
  • Pregnant women and women that are breast feeding
  • Patients with multiple (2 or more) prior failed ablations
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, 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 Jeffrey Goldberger
Organization
University of Miami
j-goldberger@miami.edu
305-243-4356

Study Officials

  • Raul Mitrani, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Cardiovascular Division

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 17, 2017

Study Start

April 4, 2017

Primary Completion

June 18, 2022

Study Completion

June 18, 2022

Last Updated

August 3, 2023

Results First Posted

August 3, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)