N/A
Completed N=283
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov NCT03775512 ↗Enrolled (actual)
283
Serious AEs
17.4%
Results posted
Mar 2023
Primary outcomePrimary: Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis — 0; 0 Percentage of Participants
Summary
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis |
0; 0 | — |
| PRIMARY Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding |
3.6; 2.4 | — |
| PRIMARY Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes |
76.3; 67.5 | — |
| SECONDARY Number of Participants With Unanticipated Adverse Device Effects (UADEs) |
0; 0 | — |
| SECONDARY Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure |
8; 4; 4; 3; 25; 12 | — |
| SECONDARY Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure |
100; 100 | — |
| SECONDARY Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection |
42.7; 31.7 | — |
| SECONDARY Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection |
57.3; 68.3 | — |
| SECONDARY Percentage of Participants With Pulmonary Veins (PV) Touch-up |
42.7; 31.7 | — |
| SECONDARY Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins |
27.4; 20.7 | — |
| SECONDARY Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement |
31.1; 28.9; 53.3; 42.2; 44.4; 53.5 | — |
| SECONDARY Percentage of Participants Who Underwent Repeat Ablation Procedures |
10.8; 13.4 | — |
| SECONDARY Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure |
100; 100 | — |
| SECONDARY Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure |
50.0; 63.6 | — |
| SECONDARY Percentage of Participants With 12-Month Single Procedure Success |
77.3; 72.4 | — |
Eligibility Criteria
Key Inclusion Criteria
- Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.
- Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD.
- Age 18 years or older.
Key Exclusion Criteria
- Previous surgical or catheter ablation for atrial fibrillation.
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
- Valve repair or replacement or presence of a prosthetic valve.
- CABG surgery within the past 6 months (180 days).
- Any carotid stenting or endarterectomy within the past 6 months.
- Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
- Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
- Documented LA size > 50 mm.
- Documented LVEF < 40%.
- Contraindication to anticoagulation (e.g., heparin).
- MI/PCI within the past 2 months.
- Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
Data sourced from ClinicalTrials.gov (NCT03775512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.