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Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure

NCT02137187 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1830

Last updated 2021-01-20

No results posted yet for this study

Summary

There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality

Conditions

  • Permanent Atrial Fibrillation

Interventions

PROCEDURE

AV junction ablation

AV junction ablation

DEVICE

CRT

Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)

DRUG

Optimized drug therapy

Optimized drug therapy for heart failure and atrial fibrillation rate control

DEVICE

ICD

Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines

Sponsors & Collaborators

  • Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

    lead OTHER

Principal Investigators

  • Claudio Marsano, MD · Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-15
Primary Completion
2021-05-15
Completion
2021-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137187 on ClinicalTrials.gov