Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atrial Fibrillation Ablation Compared to Rate Control Strategy in Patients With Impaired Left Ventricular Function (AFARC-LVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Centro Cardiologico Monzino
Humanitas Research Hospital IRCCS, Rozzano-Milan
University of Padua
Policlinico Casilino ASL RMB
Information provided by (Responsible Party):
Fiorenzo Gaita, University of Turin, Italy

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).


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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 6-minute walking test distance, meaused in metres [ Time Frame: 3, 6 and 12 months ]
  2. quality of life, assessed with Minnesota Living With Heart Failure questionnaire score [ Time Frame: 3, 6 and 12 months ]
  3. number of heart failure hospitalizations [ Time Frame: 3, 6 and 12 months ]
  4. number of ICD interventions [ Time Frame: 3, 6 and 12 months ]
  5. number of patients suffering ischemic or hemorrhagic stroke [ Time Frame: 3, 6 and 12 months ]
  6. all-cause mortality [ Time Frame: 3, 6 and 12 months ]
    defined as number of patients died during follow-up

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509754


Contacts
Layout table for location contacts
Contact: Fiorenzo Gaita, M.D., Prof. +390116335570 fiorenzo.gaita@unito.it
Contact: Mario Matta, M.D. m.matta26@gmail.com

Sponsors and Collaborators
University of Turin, Italy
Centro Cardiologico Monzino
Humanitas Research Hospital IRCCS, Rozzano-Milan
University of Padua
Policlinico Casilino ASL RMB

Publications of Results:

Other Publications:
Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG), Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bänsch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24.

Layout table for additonal information
Responsible Party: Fiorenzo Gaita, M.D., Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02509754     History of Changes
Other Study ID Numbers: FG062015TRN
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Fiorenzo Gaita, University of Turin, Italy:
atrial fibrillation
congestive heart failure
catheter ablation
rate control
left ventricular function
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes