Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05760833
Other study ID # PULVERISE-AF-CRT
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date April 8, 2024

Study information

Verified date March 2023
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 8, 2024
Est. primary completion date April 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ablation
Ablation of either the pulmonary veins or the atrioventricular node

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause death. Occurence of all-cause death. 1 year
Primary cardiovascular hospitalization. Occurence of cardiovascular hospitalization (heart failure or stroke). 1 year
Primary Quality of life Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)). 1 year
Secondary Death from any cause Occurence of death from any cause. 1 year
Secondary Unplanned hospitalization Occurence of unplanned hospitalization related to heart failure. 1 year
Secondary death from cardiovascular disease Occurence of death from cardiovascular disease. 1 year
Secondary cerebrovascular accident. Occurence of stroke. 1 year
Secondary unplanned hospitalization for cardiovascular disease Any unplanned hospitalization for cardiovascular disease. 1 year
Secondary Any hospitaliation Any hospitalization for non-cardiovascular disease. 1 year
Secondary changes in the Kansas city cardiomyopathy questionnaire Changes in quality of life (any) 1 year
Secondary procedure related adverse events Occurence of procedure related adverse events. 1 year
Secondary atrial fibrillation-free intervals were assessed. Assessment of AF free intervals. 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy