NCT04835844

Brief Summary

The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 24, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

March 25, 2021

Last Update Submit

March 26, 2026

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • System is able to accurately identify gaps

    Incidence of accurate identification of gaps in prior ablation lines by the system

    At the time of procedure

Secondary Outcomes (1)

  • Treatment success

    Up to 12 months

Study Arms (2)

Mapping with CARTO

CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter

Device: CARTO

Mapping with RHYTHMIA

RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter.

Device: RHYTHMIA

Interventions

CARTODEVICE

Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter

Mapping with CARTO
RHYTHMIADEVICE

Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.

Mapping with RHYTHMIA

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Electrophysiology clinic patients who are considered candidates for redo paroxysmal AF ablation.

You may qualify if:

  • Adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal AF regardless of the systems or energy sources used during the pre-study ablation procedure(s).
  • Paroxysmal AF: defined as AF terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion.

You may not qualify if:

  • Persistent AF
  • Prior cardiac surgery
  • Patients with only AFL or AT as the documented recurrent arrhythmia after the pre-study AF ablation(s).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ayman Hussein, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 8, 2021

Study Start

July 24, 2020

Primary Completion

July 11, 2025

Study Completion

July 11, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

US(1)