ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients With Persistent AF

Atrial Fibrillation Clinical Trial

Official title:

Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04906668
• Other study ID #: ABLATE versus PACE
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: April 30, 2027

Study information

• Verified date: February 2024
• Source: St. Josefs-Hospital Wiesbaden GmbH
• Contact: Joachim Ehrlich, MD
• Phone: +496111771201
• Email: jehrlich[@]joho.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 99 Years

Eligibility

Inclusion Criteria:

• Persistent AF according to current ESC guideline (2020)

• Symptoms EHRA classification II - IV despite guideline indicated medical therapy

• 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 > 40 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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Cryoballoon pulmonary-vein isolation
Electrical isolation of the pulmonary-veins using cryoenergy
• Pacemaker implantation and ablation of atrioventricular-node
Pacemaker implantation and ablation of atrioventricular-node

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik Bad Nauheim	Bad Nauheim
Germany	Universitätsklinikum Essen	Essen
Germany	Klinikum Fürth	Fürth
Germany	Ev. Krankenhaus Hagen-Haspe	Hagen
Germany	St. Marien Hospital Lünen	Lünen
Germany	Universitätsklinikum Münster	Münster
Germany	BG Murnau	Murnau Am Staffelsee
Germany	St. Josefs-Hospital Wiesbaden GmbH	Wiesbaden

Sponsors (2)

Lead Sponsor	Collaborator
St. Josefs-Hospital Wiesbaden GmbH	Deutsche Herzstiftung e.V.

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment	except for protocol-indicated AVN ablation	36 months
Primary	Number of subjects requiring repeat ablation, electrical or pharmacological cardioversion for symptomatic relapse of atrial fibrillation, atrial tachycardia or flutter after blanking period		36 months
Primary	Number of subjects requiring upgrade to cardiac resynchronization therapy pacemaker due to reduced systolic left ventricular function with ejection fraction =35% in "ablate-and-pace" group		36 months
Secondary	Death from any cause		36 months
Secondary	Number of subjects with procedure-associated complications	(major bleeding by Bleeding Academic Research Consortium Definition (BARC = 2) criteria, major groin site complications prolonging inpatient stay, 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)	36 months
Secondary	Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)		36 months
Secondary	Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)	Scale 20-140 with higher score indicating worse quality-of-life.	36 months
Secondary	Deterioration of systolic LV function =10 percent		36 months
Secondary	Number of subjects requiring repeat ablation		36 months
Secondary	Number of subjects requiring anti-arrhythmic drug treatment after initial ablation		36 months
Secondary	Number of nights spent in hospital for occurrence of primary or secondary endpoints		36 months