Atrial Fibrillation Progression Trial

Atrial Fibrillation Clinical Trial

— ATTEST  

Official title:

Atrial Fibrillation Progression Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01570361
• Other study ID #: ATTEST
• Status: Terminated
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

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