NCT03858361

Brief Summary

Data collection from atrial flutter patients before, during and after undergoing catheter-based electrophysiological (EP) intervention in order to develop a patient specific optimized therapy (PSOT) to improve specific patient's arrhythmia treatment for Atrial Flutter.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
566

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

September 13, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

3.5 years

First QC Date

February 20, 2019

Last Update Submit

June 6, 2023

Conditions

Data Collection

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia recurrence The number of Arrhythmia recurrence

    The number of arrhythmia recurrence

    3 months

Interventions

Atrial Flutter AblationDEVICE

Catheter-based electrophysiological (EP) intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Arrhythmia patients with Atrial Flutter indicated for EP procedures.

You may qualify if:

  • Subject is at least 18 years of age.
  • Subject signed a written Informed Consent form to participate in the study, prior to any study related procedures.
  • Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
  • A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
  • Subject is deemed amenable to therapeutic ablation for atrial flutter.

You may not qualify if:

  • Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
  • Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
  • Patient had experienced previous stroke (TIA or CVA).
  • Thrombi detected in the heart.
  • Known marked valvar insufficiency.
  • Life expectancy less than 12 months.
  • Known severe renal insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Health South Florida

Florida City, Florida, 33143, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 28, 2019

Study Start

September 13, 2019

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

US(1)