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.

Paroxysmal Atrial Fibrillation Clinical Trial

— QDOT PAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324201
• Other study ID #: QDOT PAS
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: March 2028

Study information

• Verified date: March 2024
• Source: Heart Rhythm Clinical and Research Solutions, LLC
• Contact: Carla Perna
• Phone: 205-223-0960
• Email: cperna[@]hrcrs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 to this sub-study per inclusion and exclusion criteria.

Description:

Enrolled QDOT PAS subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation (PAF) enrolled in the REAL AF registry. These enrolled subjects will be treated with the commercially available QDOT MICRO™ system (QDOT MICRO™ catheter and nGEN™ generator) in conjunction with VISITAG SURPOINT™ Module. Subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 2028
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF

2. 18 years of age or older

3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study

4. Willing and able to provide informed consent for this sub-study

Exclusion Criteria:

1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)

2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan

3. Persistent or long-standing persistent AF

4. In the opinion of the investigator, any known contraindication to an ablation procedure

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Ablation Procedure
Ablation Procedure for paroxysmal atrial fibrillation

Locations

Country	Name	City	State
United States	Mercy Health	Janesville	Wisconsin
United States	Centra Health, Inc.dba Stroobants Cardiovascular Center	Lynchburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Heart Rhythm Clinical and Research Solutions, LLC	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module	Adverse events from post-procedure through 7-day post ablation visit.	Day 0-7 post ablation
Primary	Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.	Freedom from atrial arrhythmia recurrence at 12 months post procedure.	12 months
Primary	Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.	Freedom from atrial arrhythmia recurrence at 24 months post procedure.	24 months
Primary	Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.	Freedom from atrial arrhythmia recurrence at 36 months post procedure.	36 months