Atrial Fibrillation Ablation Compared to Rate Control Strategy in Patients With Impaired Left Ventricular Function (AFARC-LVF)
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|ClinicalTrials.gov Identifier: NCT02509754|
Recruitment Status : Unknown
Verified December 2015 by Fiorenzo Gaita, University of Turin, Italy.
Recruitment status was: Not yet recruiting
First Posted : July 28, 2015
Last Update Posted : December 3, 2015
Atrial fibrillation (AF) and congestive heart failure (CHF) are two epidemics that share several physiopathological links. CHF patients present a significantly increased risk of developing AF and the related detrimental hemodynamic effects are even more relevant than in patients without CHF.
Within CHF patients rate control is the most widely used strategy to manage AF, having proved non-inferior to rhythm control strategies. However, by this strategy, the hemodynamic effects of AF persist, not contrasting the natural evolution towards progressive left ventricular (LV) function, cardiac output , and symptoms worsening. Rhythm control strategy, instead, has shown, in the general population, advantages over rate control concerning survival, quality of life and thromboembolic events. The main limitation is that antiarrhythmic therapy used to achieve this goal has several side effects, and that transcatheter AF ablation has been assessed only in modest sample size studies.
Available literature focusing on a direct comparison between two specific management strategies in patients with CHF and AF is limited to a small randomized study comparing pulmonary veins isolation to AV node ablation and biventricular PM implantation (PABA-CHF study). Additional indirect evidences may derive from meta-analyses of observational studies.
The investigators therefore designed this multicenter, randomized controlled trial aiming to assess if, in recently diagnosed (less than 6 months) and optimally treated CHF patients with impaired LV function, AF catheter ablation is effective in improving LV function and clinical functional class, potentially driving to a reduction of device implantations (ICD/CRTs).
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction||Procedure: Atrial fibrillation catheter ablation Procedure: Rate control||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Atrial Fibrillation Ablation Compared to Rate Control Strategy in Patients With Recently Diagnosed Impaired Left Ventricular Function: a Multicenter, Randomized Controlled Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Atrial fibrillation catheter ablation
Atrial fibrillation (AF) catheter ablation is performed following each Center's common practice. Activated clotting time (ACT) is maintained above 350 seconds. The left atrium (LA) is accessed by transseptal puncture or through a patent foramen ovale. A multipolar catheter and an irrigated-tip ablation catheter are inserted into the LA and a 3-dimensional reconstruction of the LA and pulmonary veins (PVs) ostia is performed. The mainstay is to obtain a complete antral PVs isolation, defined by complete elimination of PVs potentials. PVs isolation may be accompanied by the creation of linear lesions (roof line, left isthmus) or ablation of complex fractioned atrial electrograms. Patients are discharged on oral anticoagulation and optimal medical therapy. Each center will evaluate patients for ICD implantation; a loop recorder may be implanted if within routine clinical practice.
Procedure: Atrial fibrillation catheter ablation
Experimental: Rate control arm
Patients randomized to rate control only arm will undergo ICD implantation and optimization of the rate control therapy. In case of uncontrolled ventricular rate at 24-h ECG Holter, defined as a mean resting heart rate higher than 90 bpm, patients will receive atrioventricular (AV) node ablation and resyncronization therapy (CRT-D) implantation, performed following common practice at each Center. In case of failure or technical difficulties of the transvenous approach, epicardial screw-in or steroid-eluting passive lead is implanted via a limited thoracotomy. Transcatheter AV node ablation is performed as follows: a non-irrigated tip ablation catheter is introduced on the right side of the interatrial septum and ablation performed on the fast pathway region or the smallest His bundle signal. The goal of the procedure is AV modulation below 30 bpm or complete AV block.
Procedure: Rate control
Composite of optimal medical therapy and device implantation
- composite of the improvement of left ventricular ejection fraction above 35% and concomitant NYHA class lower than II, measured as number of patients reporting both conditions at follow-up [ Time Frame: 6 months ]
- 6-minute walking test distance, meaused in metres [ Time Frame: 3, 6 and 12 months ]
- quality of life, assessed with Minnesota Living With Heart Failure questionnaire score [ Time Frame: 3, 6 and 12 months ]
- number of heart failure hospitalizations [ Time Frame: 3, 6 and 12 months ]
- number of ICD interventions [ Time Frame: 3, 6 and 12 months ]
- number of patients suffering ischemic or hemorrhagic stroke [ Time Frame: 3, 6 and 12 months ]
- all-cause mortality [ Time Frame: 3, 6 and 12 months ]defined as number of patients died during follow-up
- periprocedural major complications [ Time Frame: 3 months ]composite of death, cerebrovascular accidents, cardiac tamponade, pneumothorax, phrenic nerve persistent injury, access site pseudoaneurysm/fistula/hematoma requiring drainage
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509754
|Contact: Fiorenzo Gaita, M.D., Prof.||+firstname.lastname@example.org|
|Contact: Mario Matta, M.D.||email@example.com|