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Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
NA trial testing THERMOCOOL SMARTTOUCH SF-5D Catheter in Paroxysmal Atrial Fibrillation in 54 participants. Completed in 8 October 2018.
| Lead sponsor | Biosense Webster, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 2 April 2018 |
| Primary completion | 8 October 2018 |
| Estimated completion | 8 October 2018 |
| Sites | 7 locations across Belgium, Austria, Italy, Czechia |
Biosense Webster, Inc. — full company profile →
18 and older, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
| Group | Value | 95% CI |
|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter | 52 |
Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.
| Group | Value | 95% CI |
|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter | 2 |
Time frame: 3 months post-procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | THERMOCOOL SMARTTOUCH SF-5… |
|---|---|---|
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | — |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | — |
| Atrial flutter | Cardiac disorders | — |
| Syncope | Nervous system disorders | — |
| Reaction | System | THERMOCOOL SMARTTOUCH SF-5… |
|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Cerebral ischaemia | Nervous system disorders | — |
| Haematoma | Vascular disorders | — |
| Erosive oesophagitis | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Hiatus hernia | Gastrointestinal disorders | — |
| Atrioventricular block first degree | Cardiac disorders | — |
| Bundle branch block left | Cardiac disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Sinus bradycardia | Cardiac disorders | — |
| Goitre | Endocrine disorders | — |
| Diverticulum gastric | Gastrointestinal disorders | — |
| Gastric disorder | Gastrointestinal disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| Gastrointestinal disorder | Gastrointestinal disorders | — |
| Oesophageal disorder | Gastrointestinal disorders | — |
| Oesophageal mucosa erythema | Gastrointestinal disorders | — |
| Oesophageal polyp | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Oesophageal candidiasis | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Viral upper respiratory tract infection | Infections and infestations | — |
| Duodenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Syncope | Nervous system disorders | — |
| Haematuria | Renal and urinary disorders | — |
| Hypertension | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
Most-reported serious reactions: Oesophageal ulcer haemorrhage, Vascular pseudoaneurysm, Atrial flutter, Syncope.
Data from ClinicalTrials.gov NCT03459196 adverse events section.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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