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Atrial Fibrillation Progression Trial
Phase 4 trial testing Catheter Ablation in Atrial Fibrillation in 255 participants. Terminated before completion.
| Lead sponsor | Biosense Webster, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 255 |
| Start date | 13 February 2012 |
| Primary completion | 19 December 2018 |
| Estimated completion | 19 December 2018 |
Biosense Webster, Inc. — full company profile →
60 and older, any sex, with 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.
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | NA | NA – NA |
| Antiarrhythmic Drug (AAD) Therapy | NA | NA – NA |
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | NA | NA – NA |
| Antiarrhythmic Drug (AAD) Therapy | NA | NA – NA |
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | NA | NA – NA |
| Antiarrhythmic Drug (AAD) Therapy | NA | NA – NA |
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 1.3 | 0.2 – 8.6 |
| Antiarrhythmic Drug (AAD) Therapy | 6.5 | 3.2 – 13.2 |
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 2.4 | 0.6 – 9.4 |
| Antiarrhythmic Drug (AAD) Therapy | 12.4 | 7.2 – 21.0 |
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 2.4 | 0.6 – 9.4 |
| Antiarrhythmic Drug (AAD) Therapy | 17.5 | 10.7 – 27.8 |
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 0.0 | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 1.5 | 0.2 – 10.4 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 7.7 | 1.1 – 43.4 |
Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is \>= 2, then subject had at least one repeat procedure.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 0.9 | ± 0.57 |
| Radiofrequency (RF) Ablation 2nd Treatment | 1.1 | ± 0.26 |
Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines.
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 0.8 | ± 1.05 |
| Antiarrhythmic Drug (AAD) Therapy | 1.0 | ± 1.23 |
Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 51 | |
| Antiarrhythmic Drug (AAD) Therapy | 55 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 49 | |
| Antiarrhythmic Drug (AAD) Therapy | 42 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 41 | |
| Antiarrhythmic Drug (AAD) Therapy | 35 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 37 | |
| Antiarrhythmic Drug (AAD) Therapy | 30 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 20 | |
| Antiarrhythmic Drug (AAD) Therapy | 23 |
Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 17 | |
| Antiarrhythmic Drug (AAD) Therapy | 20 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 17 | |
| Antiarrhythmic Drug (AAD) Therapy | 45 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 20 | |
| Antiarrhythmic Drug (AAD) Therapy | 38 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 16 | |
| Antiarrhythmic Drug (AAD) Therapy | 30 |
| Group | Value | 95% CI |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | 10 | |
| Antiarrhythmic Drug (AAD) Therapy | 17 |
Time frame: 3 years follow up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Radiofrequency (RF) Ablati… | Antiarrhythmic Drug (AAD) … | Antiarrhythmic Drug (AAD) … | Radiofrequency (RF) Ablati… |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Chest pain | General disorders | — | — | — | — |
| Pericarditis | Cardiac disorders | — | — | — | — |
| Ventricular tachyarrhythmia | Cardiac disorders | — | — | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — | — | — |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Haematoma | Vascular disorders | — | — | — | — |
| Haemorrhage | Vascular disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — | — | — |
| Angina unstable | Cardiac disorders | — | — | — | — |
| Arrhythmia | Cardiac disorders | — | — | — | — |
| Atrial tachycardia | Cardiac disorders | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — | — |
| Cardiac tamponade | Cardiac disorders | — | — | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — | — | — |
| Intracardiac thrombus | Cardiac disorders | — | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — | — |
| Sinus node dysfunction | Cardiac disorders | — | — | — | — |
| Reaction | System | Radiofrequency (RF) Ablati… | Antiarrhythmic Drug (AAD) … | Antiarrhythmic Drug (AAD) … | Radiofrequency (RF) Ablati… |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — |
| Thyroid disorder | Endocrine disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Chest pain | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Anaphylactic shock | Immune system disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Hypertensive crisis | Vascular disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — | — |
| Aortic valve incompetence | Cardiac disorders | — | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — | — |
| Atrial thrombosis | Cardiac disorders | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Cardiac failure chronic | Cardiac disorders | — | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — | — |
| Cardiac valve disease | Cardiac disorders | — | — | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — |
| Supraventricular extrasystoles | Cardiac disorders | — | — | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — | — | — |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | — | — | — | — |
| Deafness | Ear and labyrinth disorders | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Large intestine polyp | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Proctalgia | Gastrointestinal disorders | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Vessel puncture site pain | General disorders | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
Most-reported serious reactions: Atrial fibrillation, Atrial flutter, Bradycardia, Chest pain, Pericarditis, Ventricular tachyarrhythmia, Cholecystitis acute, Pulmonary oedema.
Data from ClinicalTrials.gov NCT01570361 adverse events section.
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing