NCT00964392: AF Registry

NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

Completed Phase 4 Results posted Last updated 4 February 2025

What this trial tests

Phase 4 trial testing Atrial fibrillation ablation in Paroxysmal Atrial Fibrillation in 437 participants. Completed in 5 January 2018.

Timeline

1 September 2009

Primary endpoint
1 September 2013

5 January 2018

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	437
Start date	1 September 2009
Primary completion	1 September 2013
Estimated completion	5 January 2018

Drugs / interventions tested

• Atrial fibrillation ablation

Conditions studied

• Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure. Primary · Seven days post ablation procedure

The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-

Group	Value	95% CI
More-experienced Physicians	3.2	0 – 7.2
Less-experienced Physicians	6.4	0 – 9.3

Percentage of Subjects Experienced Serious Adverse Events. Secondary · First study day to 5 year post-ablation

The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).

1 to 30 days post-ablation

Group	Value	95% CI
More-experienced Physicians	6.4
Less-experienced Physicians	12.1

31 days to 365 days post-ablation

Group	Value	95% CI
More-experienced Physicians	11.2
Less-experienced Physicians	14.5

366 to 730 days post-ablation

Group	Value	95% CI
More-experienced Physicians	14.9
Less-experienced Physicians	7.4

More than 730 days post-ablation

Group	Value	95% CI
More-experienced Physicians	11.0
Less-experienced Physicians	11.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Five years post-ablation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

More-experienced Physicians

Serious: 41/125 (33%)

Deaths: —

Less-experienced Physicians

Serious: 95/282 (34%)

Deaths: —

Serious adverse events (112 terms)

Reaction	System	More-experienced Physicians	Less-experienced Physicians
Atrial fibrillation	Cardiac disorders	—	—
Pericardial effusion	Cardiac disorders	—	—
Atrial flutter	Cardiac disorders	—	—
Chest pain	Cardiac disorders	—	—
Bradycardia	Cardiac disorders	—	—
Pneumonia	Infections and infestations	—	—
Haematoma	Vascular disorders	—	—
Atrial tachycardia	Cardiac disorders	—	—
Syncope	Cardiac disorders	—	—
Ventricular tachycardia	Cardiac disorders	—	—
Knee arthroplasty	Surgical and medical procedures	—	—
Cardiac ablation	Surgical and medical procedures	—	—
Dyspnoea	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Cardiac tamponade	Cardiac disorders	—	—
Fluid overload	Cardiac disorders	—	—
Gastroenteritis	Gastrointestinal disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Cardiac pacemaker insertion	Surgical and medical procedures	—	—
Hypotension	Vascular disorders	—	—
Sick sinus syndrome	Cardiac disorders	—	—
Angina pectoris	Cardiac disorders	—	—

Other adverse events (207 terms — click to expand)

Reaction	System	More-experienced Physicians	Less-experienced Physicians
Atrial fibrillation	Cardiac disorders	—	—
Atrial flutter	Cardiac disorders	—	—
Chest pain	Cardiac disorders	—	—
Atrial tachycardia	Cardiac disorders	—	—
Palpitations	Cardiac disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	—	—
Dysuria	Renal and urinary disorders	—	—
Cardiac ablation	Surgical and medical procedures	—	—
Pericardial effusion	Cardiac disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Haematoma	Vascular disorders	—	—
Cardioversion	Surgical and medical procedures	—	—
Dyspnoea	Cardiac disorders	—	—
Dizziness	Cardiac disorders	—	—
Vision blurred	Eye disorders	—	—
Oropharyngeal pain	Gastrointestinal disorders	—	—
Vessel puncture site haematoma	General disorders	—	—
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary vein stenosis	Respiratory, thoracic and mediastinal disorders	—	—
Chest discomfort	Cardiac disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Procedural pain	General disorders	—	—
Herpes zoster	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Endotracheal intubation complication	Injury, poisoning and procedural complications	—	—
Fall	Injury, poisoning and procedural complications	—	—
Procedural hypotension	Injury, poisoning and procedural complications	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Arrhythmia	Cardiac disorders	—	—
Oedema peripheral	Cardiac disorders	—	—
Arrhythmia supraventricular	Cardiac disorders	—	—
Dyspnoea exertional	Cardiac disorders	—	—
Syncope	Cardiac disorders	—	—
Ventricular tachycardia	Cardiac disorders	—	—
Ocular hyperaemia	Eye disorders	—	—

Most-reported serious reactions: Atrial fibrillation, Pericardial effusion, Atrial flutter, Chest pain, Bradycardia, Pneumonia, Haematoma, Atrial tachycardia.

Data from ClinicalTrials.gov NCT00964392 adverse events section.

Sponsor's own description

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.