ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients With Persistent AF
Study Details
Study Description
Brief Summary
As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk.
In case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (PVI) as invasive treatment option. However, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. Although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. Therefore, repeated interventions are often necessary.
An effective method for frequency control is atrioventricular (AV) node ablation after implantation of a pacemaker ("ablate-and-pace"). In this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs.
There are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients.
The ABLATE versus PACE trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cryoballoon pulmonary-vein isolation
|
Procedure: Cryoballoon pulmonary-vein isolation
Electrical isolation of the pulmonary-veins using cryoenergy
|
| Active Comparator: Ablation of atrioventricular-node and pacemaker implantation
|
Procedure: Pacemaker implantation and ablation of atrioventricular-node
Pacemaker implantation and ablation of atrioventricular-node
|
Outcome Measures
Primary Outcome Measures
- Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period, cardiac decompensation or pacemaker complications requiring inpatient treatment [12 months]
except for protocol-indicated AVN ablation
- Number of subjects requiring repeat ablation, electrical or pharmacological cardioversion for symptomatic relapse of atrial fibrillation, atrial tachycardia or flutter after blanking period [12 months]
- Number of subjects requiring upgrade to cardiac resynchronization therapy pacemaker in "ablate-and-pace" group [12 months]
Secondary Outcome Measures
- Death from any cause [12 months]
- Number of subjects with procedure-associated complications [12 months]
(major bleeding by Bleeding Academic Research Consortium Definition (BARC ≥ 2) criteria, pacemaker pocket bleeding prolonging inpatient stay, pericardial effusion, cerebrovascular or systemic embolism, phrenic nerve palsy, lead dislodgment, lead perforation, infection including pacemaker pocket infection, lead infection / pacemaker related endocarditis)
- Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA) [12 months]
- Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) [12 months]
Scale 20-140 with higher score indicating worse quality-of-life.
- Deterioration of systolic LV function ≥10 percent [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Persistent AF (duration < 12 months) according to current ESC guideline (2020)
-
Symptoms EHRA classification II - IV
-
Age ≥ 75 years
-
Capability of giving written informed consent
Exclusion Criteria:
-
impaired systolic left ventricular function (ejection fraction < 50%)
-
High-grade (III°) left cardiac valvular disease
-
pre-implanted pacemaker
-
bradycardia-indication for pacemaker
-
Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
-
contraindication for PVI or pacemaker-implantation
-
contraindication for oral anticoagulation
-
body-mass-index BMI > 35 kg/m2
-
inability to give written informed consent
-
concomitant participation in another registered trial
-
life expectancy < 12 months
-
reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kerckhoff-Klinik Bad Nauheim | Bad Nauheim | Germany | 61231 | |
| 2 | Universitätsklinikum Münster | Münster | Germany | 48149 | |
| 3 | St. Josefs-Hospital Wiesbaden GmbH | Wiesbaden | Germany | 65189 |
Sponsors and Collaborators
- St. Josefs-Hospital Wiesbaden GmbH
Investigators
- Principal Investigator: Joachim Ehrlich, MD, St. Josefs-Hospital Wiesbaden GmbH
- Principal Investigator: Andreas Boehmer, MD, St. Josefs-Hospital Wiesbaden GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
- Buiatti A, von Olshausen G, Barthel P, Schneider S, Luik A, Kaess B, Laugwitz KL, Hoppmann P. Cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: an updated meta-analysis of randomized and observational studies. Europace. 2017 Mar 1;19(3):378-384. doi: 10.1093/europace/euw262.
- Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
- Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):313-20. doi: 10.1161/CIRCOUTCOMES.110.958165. Epub 2011 May 3.
- Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27.
- Vlachos K, Letsas KP, Korantzopoulos P, Liu T, Efremidis M, Sideris A. A review on atrioventricular junction ablation and pacing for heart rate control of atrial fibrillation. J Geriatr Cardiol. 2015 Sep;12(5):547-54. doi: 10.11909/j.issn.1671-5411.2015.05.005. Review.
- Weerasooriya R, Khairy P, Litalien J, Macle L, Hocini M, Sacher F, Lellouche N, Knecht S, Wright M, Nault I, Miyazaki S, Scavee C, Clementy J, Haissaguerre M, Jais P. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up? J Am Coll Cardiol. 2011 Jan 11;57(2):160-6. doi: 10.1016/j.jacc.2010.05.061.
- ABLATE versus PACE