The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Study ID
NCT06324201
Status
Recruiting
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Conditions

  • Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ablation Procedure — DEVICE
    Ablation Procedure for paroxysmal atrial fibrillation

Study Details

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.

Key Dates

Start date
Feb 27, 2024
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
250 participants (estimated)

Primary Outcome Measure

Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module [ Time Frame: Day 0-7 post ablation ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Arrhythmia Institute at GrandviewBirminghamAlabama35209
Anil Rajendra, MD (PRINCIPAL_INVESTIGATOR)
Mobile Cardiology AssociatesMobileAlabama36608
Matthew E Quin, MD (PRINCIPAL_INVESTIGATOR)
Community Memorial Health SystemVenturaCalifornia93003
Jonathan Dukes, MD (PRINCIPAL_INVESTIGATOR)
Medical City - HCAAuroraColorado80012
Christopher Porterfield, MD (PRINCIPAL_INVESTIGATOR)
Naples Community HospitalNaplesFlorida34102-
Sarasota Memorial HealthSarasotaFlorida34239
Antonio Moretta, MD (PRINCIPAL_INVESTIGATOR)
Piedmont HealthcareAtlantaGeorgia30309
Sandeep Goyal, MD (PRINCIPAL_INVESTIGATOR)
Norton Heart and Vascular InstituteLouisvilleKentucky40205
Kent Morris, MD (PRINCIPAL_INVESTIGATOR)
The Brigham and Womens HospitalBostonMassachusetts02115
Jorge Romero, MD (PRINCIPAL_INVESTIGATOR)
Sparrow Clinical Research InstituteLansingMichigan48912
Ali Sheikh, DO (PRINCIPAL_INVESTIGATOR)
Trinity Health-Michigan HeartYpsilantiMichigan48197
Mohammad-Ali Jazayeri, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Alexandru Costea, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45221
Srinivas Rajsheker, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania (UPENN)PhiladelphiaPennsylvania19104
Benjamin D'Souza, MD (PRINCIPAL_INVESTIGATOR)
Allegheny HealthPittsburghPennsylvania15212
Joshua Silverstein, MD (PRINCIPAL_INVESTIGATOR)
Centra Health, Inc.dba Stroobants Cardiovascular CenterLynchburgVirginia24501
Cindy Baumann
Mathhew Sackett (PRINCIPAL_INVESTIGATOR)
Bon Secours Medical Group - Richmond Specialty CareRichmondVirginia23226
An Bui, MD (PRINCIPAL_INVESTIGATOR)
Valley Health SystemWinchesterVirginia22601
Emmanuel Ekanem, MD (PRINCIPAL_INVESTIGATOR)
Multicare Health Systems-Pulse HeartPuyallupWashington98372
Tariq Salam, MD (PRINCIPAL_INVESTIGATOR)
Franciscan Heart and Vascular AssociatesTacomaWashington98401
Nasir Shariff, MD (PRINCIPAL_INVESTIGATOR)
Mercy HealthJanesvilleWisconsin53548
Kaitlyn Phetteplace
Imdad Ahmed (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Arrhythmia Institute at Grandview· Birmingham, ALMobile Cardiology Associates· Mobile, ALCommunity Memorial Health System· Ventura, CAMedical City - HCA· Aurora, CONaples Community Hospital· Naples, FLSarasota Memorial Health· Sarasota, FL

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