Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)

NCT02944968 | Completed Results DMC FDA Device

• 1 other identifier: MQDT-166
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.

Conditions

Atrial Fibrillation

Keywords

Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population

  Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.

  Day of ablation procedure

Secondary Outcomes (1)

• Number of Participants With Early Onset Primary Adverse Events in Total Safety Population

  Seven Days Post Procedure

Study Arms (1)

Treatment group

EXPERIMENTAL

Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.

Device: THERMOCOOL SMARTTOUCH® SF-5D catheter

Interventions

THERMOCOOL SMARTTOUCH® SF-5D catheter DEVICE

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for this study must meet ALL of the following criteria:
• Age 18 or older
• Patients who have signed the Patient Informed Consent Form (ICF)
• Subjects diagnosed with symptomatic documented PAF\* who are candidates for catheter ablation
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)

You may not qualify if:

• Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous ablation for atrial fibrillation.
• Previously diagnosed with persistent AF.
• Documented Left Atrial thrombus
• Any carotid stenting or endarterectomy
• LA size \>50mm
• LVEF \<40%
• Uncontrolled heart failure or NYHA function class III and IV
• History of blood clotting or bleeding abnormalities or contraindication to anticoagulation ( heparin, warfarin, or dabigatran)
• History of a documented thromboembolic event (including TIA) within the past 12 months.
• Previous PCI/MI within the past 3 months
• Previous cardiac surgery (e.g CABG) in conjunction with valve surgery or any valvular cardiac surgical/percutaneous procedure (e.g ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve) within the past 6 months.
• Awaiting cardiac transplantation or other cardiac surgery within the next 6 months.
• Unstable angina

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nathalie Macours, Clinical Research Director
• Organization: Johnson and Johnson Medical NV/SA

nmacours1@its.jnj.com

+32 2 746 35 27

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2016
• Primary Completion: August 6, 2018
• Study Completion: August 6, 2018
• Last Updated: February 4, 2025
• Results First Posted: November 18, 2019

Record last verified: 2025-01