Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-04-08

Brief Summary

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Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.

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Detailed Description

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Conditions

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Atrial Fibrillation Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulmonary vein isolation

Ablation of the pulmonary veins.

Group Type ACTIVE_COMPARATOR

Ablation

Intervention Type PROCEDURE

Ablation of either the pulmonary veins or the atrioventricular node

atrioventricular node ablation.

Ablation of the atrioventricular node.

Group Type ACTIVE_COMPARATOR

Ablation

Intervention Type PROCEDURE

Ablation of either the pulmonary veins or the atrioventricular node

Interventions

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Ablation

Ablation of either the pulmonary veins or the atrioventricular node

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and optimal medical therapy according to current guidelines.
* Patients with paroxysmal or persistent AF, having AF or HF related symptoms.
* Patient with paroxysmal AF should have \>25% burden or inadequate biventricular pacing (\<95%) based on device counters.
* The patient is willing and able to comply with the protocol and has provided written informed consent.
* Age ≥ 18 years

Exclusion Criteria

* Documented left atrial diameter \> 6 cm (parasternal long axis).
* Longstanding persistent AF longer than 2 years.
* Contraindication to chronic anticoagulation therapy or heparin
* Previous left heart ablation procedure for AF
* Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment
* Untreated hypothyroidism or hyperthyroidism
* Enrolment in another investigational drug or device study.
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
* Mental or physical inability to participate in the study.
* Listed for heart transplant.
* Cardiac assist device implanted.
* Planned cardiovascular intervention.
* Life expectancy ≤ 12 months.
* Uncontrolled hypertension.
* Requirement for dialysis due to terminal renal failure.
* Participation in another telemonitoring concept

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No