Atrial Fibrillation Ablation Compared to Rate Control Strategy in Patients With Impaired Left Ventricular Function

NCT02509754 | Unknown Phase 4 DMC

• 1 other identifier: FG062015TRN
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Persistent Atrial Fibrillation; Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction

Keywords

atrial fibrillation; congestive heart failure; catheter ablation; rate control; left ventricular function

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (7)

• 6-minute walking test distance, meaused in metres

  3, 6 and 12 months

• quality of life, assessed with Minnesota Living With Heart Failure questionnaire score

  3, 6 and 12 months

• number of heart failure hospitalizations

  3, 6 and 12 months

• number of ICD interventions

  3, 6 and 12 months

• number of patients suffering ischemic or hemorrhagic stroke

  3, 6 and 12 months

Study Arms (2)

Atrial fibrillation catheter ablation

EXPERIMENTAL

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

Rate control arm

EXPERIMENTAL

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

Interventions

Atrial fibrillation catheter ablation PROCEDURE

Atrial fibrillation catheter ablation

Rate control PROCEDURE

Composite of optimal medical therapy and device implantation

Rate control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent (no longer than 6 months) diagnosis of congestive heart failure, defined as left ventricular ejection fraction lower or equal than 35% along with the presence of symptoms of heart failure, with a NYHA class II, III or ambulatory IV;
• Optimal medical therapy from at least 3 months (including a beta-blocker, an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) and, in NYHA III and IV patients, spironolactone);
• Persistent atrial fibrillation (at least 3 months or, alternatively, a minimum of two previous episodes lasting longer than 7 days);
• Refractory to at least one, or intolerant to, antiarrhythmic drug/s;
• Must be able to provide written informed consent.

You may not qualify if:

• Reversible causes of atrial fibrillation or congestive heart failure;
• Permanent or long-standing persistent atrial fibrillation (lasting more than 1 year);
• Previous surgical or transcatheter AF ablation;
• Previously implanted CRT with or without concomitant AV node ablation;
• QRS duration above 150 msec or above 120 msec in the presence of complete left bundle branch block (class IIa indication for CRT implantation);
• Life expectancy of one year or less;
• High likelihood of undergoing cardiac transplantation within the next year;
• Contraindication to anticoagulant therapy;
• Documented intraatrial thrombus, tumor, or other abnormality that precludes catheter introduction and manipulation;
• Inability to perform a 6-minute walking test;
• Absence of optimal medical therapy as previously described;
• Cardiac surgery, myocardial infarction or percutaneous coronary intervention within the previous 3 months.

Sponsors & Collaborators

• University of Turin, Italy: lead
• Centro Cardiologico Monzino: collaborator
• Humanitas Research Hospital IRCCS, Rozzano-Milan: collaborator
• University of Padova: collaborator
• Policlinico Casilino ASL RMB: collaborator

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MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Fiorenzo Gaita, M.D., Prof.

CONTACT

+390116335570; fiorenzo.gaita@unito.it

Mario Matta, M.D.

CONTACT

m.matta26@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 28, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 3, 2015

Record last verified: 2015-12