Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00652522
Other study ID # AF06003AF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2008
Est. completion date July 13, 2017

Study information

Verified date January 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.


Description:

Atrial fibrillation is the most common sustained cardiac arrhythmia affecting 5% of people older than 65 years. It is associated with a 5 times increase of the risk of stroke in patients who are not receiving anticoagulant therapy and a doubling of the rate of death in all patients.

Congestive heart failure (CHF) and atrial fibrillation (AF) often co-exist, where one condition is promoting the development of the other and worsens its condition.

It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent (for a minimum of 1 week to a maximum of 1 year duration) or longstanding persistent (for a minimum of 1 year to a maximum of 4 years) atrial fibrillation, low LVEF (<=35%) and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.

Patients meeting the inclusion and exclusion criteria will be randomized in a 1:1 fashion in an unblinded, parallel arm treatment format to either drug therapy (directed at rate or rhythm control) or catheter ablation.

All therapies will be established and optimized in a 3 month treatment initiation phase (Blanking Period) starting with randomization. For all morbidity and mortality end-points, intention-to-treat analysis will begin at randomization. Efficacy with respect to AF treatment will be established for long-term follow up beginning after 3-month initiation phase.

Improvement of LVEF within 12 month is the primary endpoint of this study. The transthoracic echocardiographic (TTE) assessment at enrollment, discharge and 12 months follow-up follows a standardized protocol. The assessments are analyzed, calculated and expressed by an independent Core Lab.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date July 13, 2017
Est. primary completion date July 13, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Having signed and dated Patient Informed Consent

- Having an indication for ICD or CRT-D therapy as indicated by current valid guidelines or having been implanted with an ICD or CRT-D

- Symptomatic atrial fibrillation (persistent AF (for a minimum of 1 week to a maximum of 1 year) or longstanding persistent AF (for a minimum of 1 year to a maximum of 4 years)) irrespective of the duration of paroxysmal AF

- Ejection fraction = 35% as assessed by transthoracic echocardiography

- Left atrial diameter of less than 60 mm in parasternal diameter during transthoracic echocardiographic study

- ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) related to symptomatic episodes

- Having typical symptoms of heart failure NYHA II - III

- Patients > 30 days under optimal medical treatment for heart failure and CRT therapy in case of a pre-implanted CRT-D device

- Age 18 - 75 years

- Willing to participate in randomized trial

- Willing and able to participate in 12 months follow-up period

Exclusion Criteria:

- Longstanding persistent (> 4 years history) or paroxysmal atrial fibrillation

- Having a previously implanted pacemaker

- Having underlying valvular heart disease unless the disease has been corrected

- Patients with acute myocardial infarction

- Patients who have had previous pulmonary vein isolation procedures

- Patients with atrial fibrillation secondary to a reversible cause

- Known presence of intracardiac or other thrombi

- Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment

- Patients with other medical condition (i.e., cancer, alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)

- History of bleeding diathesis or suspected pro-coagulant state

- Contraindication to anticoagulation therapy

Study Design


Intervention

Device:
ICD/CRT implant
Implantation of a ICD/ CRT device if not yet implanted
Procedure:
AF ablation
Atrial Fibrillation ablation by pulmonary vein isolation
Other:
Best Medical Treatment
Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.

Locations

Country Name City State
Germany Herz- und Gefaesszentrum Bad Bevensen Bad Bevensen
Germany Universitäts-Herzzentrum Freiburg - Bad Krozingen Bad Krozingen
Germany Kerckhoff-Klinik gGmbH Bad Nauheim
Germany Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK) Berlin
Germany Herzzentrum Dresden Dresden
Germany Asklepios Klinik St. Georg Hamburg
Germany Universitäres Herzzentrum Hamburg GmbH / UKE Hamburg
Germany Klinikum der Ruprecht-Karls-Universität Heidelberg Heidelberg
Germany Klinikum Ingolstadt GmbH Ingolstadt
Germany Herzzentrum Leipzig GmbH Leipzig
Germany Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen
Germany Klinikum Großhadern der Ludwig-Maximilians-Universität München
Germany Herzzentrum am Universitätsklinikum Münster Münster
Germany St. Adolf-Stift Reinbek Reinbek
Hungary Semmelweis University Budapest
Spain Hospital Universitari Clinic Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Hungary,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE) evaluated by Core Lab 12months
Secondary Recurrence of atrial tachyarrhythmia diagnosed by daily ECG via ECG-recording card 9 months
Secondary Exercise capacity in 6 min walk test 12 months
Secondary Quality of life assessed by Minnesota Quality of Life Questionnaire 12 months
Secondary AF burden assessed by ICD/CRT-D device memory in SJM devices 9 months
Secondary Adverse events 12 months
Secondary Mortality 12 months
Secondary Number of adequate and inadequate ICD interventions 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy