Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01570361
Other study ID # ATTEST
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 13, 2012
Est. completion date December 19, 2018

Study information

Verified date April 2020
Source Biosense Webster, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).


Recruitment information / eligibility

Status Terminated
Enrollment 255
Est. completion date December 19, 2018
Est. primary completion date December 19, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

1. Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with = 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )

2. HATCH Score of at least =1 and =4.

3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).

4. Age 60 years or older.

5. Left atrium (LA) diameter = 55mm by TTE.

6. Left ventricle (LV) ejection fraction =50% when in sinus rhythm or LV ejection fraction =35% when in atrial fibrillation.

NOTE: For patients entering the study in AF with an ejection fraction =35% and <50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is >50% the subject can continue in the study.

7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.

Exclusion Criteria:

1. Patients awaiting cardiac transplantation or other cardiac surgery.

2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.

3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.

4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.

5. Heart failure decompensation.

6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.

7. Previously required cardioversion >48 hours after onset of atrial fibrillation/ atrial flutter.

8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.

9. Pulmonary embolism or recent atrial embolism/thrombosis.

10. Hypertrophic obstructive cardiomyopathy.

11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation).

12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation.

13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.

14. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure.

15. Prior AV nodal ablation.

16. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.

17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.

18. Medical conditions limiting expected survival to <3 years.

19. Concurrent participation in any other clinical study.

20. Prior history of non-adherence to prescribed drug regimens.

21. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation.

NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Catheter Ablation
Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
Drug:
Drug Treatment
Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide
Austria Medizinische Universitaetsklinik Graz
Austria Krankenhaus der Elisabethinen Linz
Belgium OLV Ziekenhuis Aalst
Belgium AZ Sint Jan Brugge
Germany Kerckhoff Klinik Bad Nauheim
Germany Helios Klinikum Berlin-Buch Berlin
Germany Vivantes Klinikum am Urban Berlin
Germany Herzzentrum Universitätsmedizin Göttingen Göttingen
Germany Asklepios Klinik St. Georg Hamburg
Germany Herzpraxis Altona Hamburg
Germany University Heart Center Hamburg-Eppendorf Hamburg
Hungary Semmelweis University, Cardiovascular Center Budapest
Ireland Mater Misericordiae University Hospital Dublin
Italy Ospedale Generale Regionale "F. Miulli" Bari
Italy Ospedaleria Universitaria Pisana Pisa
Italy Policlinico Casalino Roma Roma
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Latvia P. Stradins Clinical University Hospital Riga
Norway Haukeland Universitetssykehus Bergen
Poland Cardinal Stefan Wyszynski Institute of Cardiology Warszaw
Russian Federation Federal Center of Cardiovascular Surgery Krasnoyarsk
Russian Federation Federal State Institution National Research Center for Preventive Medicine of Healthcare of the Russian Federation Moscow
Russian Federation State Research Institute of Circulation Pathology Novosibirsk
Russian Federation Almazov Federal Heart, Blood and Endocrinology Centre Saint-Petersburg
Russian Federation Federal State Budgetary Scientific Institution "Research Institute for Cardiology" Tomsk
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario Virgen de la Victoria Malaga
Spain Hospital Universitario Salamanca Salamanca
Sweden Universitetssjukhuset Örebro Örebro
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom Papworth Hospital Cambridge
United Kingdom University Hospital of South Manchester Manchester

Sponsors (1)

Lead Sponsor Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Germany,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Latvia,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years 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. 3 years
Secondary Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year 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. 1 year
Secondary Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years 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. 2 years
Secondary Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year 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. 1 year
Secondary Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years 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. 2 Years
Secondary Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year 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. 3 year
Secondary Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations 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. 3 years
Secondary Number of Repeat Ablations 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. 3 years
Secondary Number of New Antiarrhythmic Drugs Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines. 3 years
Secondary Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up 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 3 months, 6 months, 1 year, 2 years, 3 years
Secondary Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up 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 3 months, 6 months, 1 year, 2 year and 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A