Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension

NCT05024630 | Unknown

• 1 other identifier: DUAL-ICE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The DUAL-ICE study is a single-center, prospective, randomized controlled study. The main purpose is to verify that renal artery cryoablation combined with pulmonary vein cryoablation can reduce the recurrence of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation and substandard hypertension, and to further verify the clinical significance of one-stop cardio-renal combined cryoablation therapy for hypertension control.

Conditions

Paroxysmal Atrial Fibrillation; Hypertension

Keywords

Renal artery cryoablation; Pulmonary vein cryoablation; One-stop cardio-renal combined cryoablation therapy

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation

  Atrial arrhythmia recurrence (documented atrial fibrillation, atrial tachycardia, or atrial flutter for ≥30 seconds during ambulatory monitoring or for ≥10 seconds on a 12-lead ECG), cardioversion, or use of class I or III antiarrhythmic drugs.

  Within 12 months after procedure (outside the 90-day blanking period).

Secondary Outcomes (1)

• Differences in office blood pressure

  Within 12 months after procedure.

Other Outcomes (2)

• Differences in 24-hour dynamic blood pressure

  Within 12 months after procedure.

• Differences in self-measured blood pressure

  Within 12 months after procedure.

Study Arms (2)

RDN+PVI group

EXPERIMENTAL

The experimental group received renal artery cryoablation and pulmonary vein cryoablation. Pulmonary vein cryoablation was first followed by renal artery cryoablation.

Procedure: Renal artery cryoablation; Procedure: Pulmonary vein cryoablation

PVI only group

SHAM COMPARATOR

The control group received pulmonary vein cryoablation alone. To ensure single blindness, the control group received femoral artery puncture and renal arteriography after cryoablation.

Procedure: Pulmonary vein cryoablation; Procedure: Renal arteriography

Interventions

Renal artery cryoablation PROCEDURE

Renal denervation were achieved by cryoablation of renal artery with cryoballoon.

RDN+PVI group

Pulmonary vein cryoablation PROCEDURE

Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.

PVI only group; RDN+PVI group

Renal arteriography PROCEDURE

Renal artery was examined by renal arteriography

PVI only group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, and \<75 years old, gender is not limited;
• Hypertensive patients with symptomatic paroxysmal atrial fibrillation to be treated by catheter ablation with substandard blood pressure. SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in patients taking at least one antihypertensive drug;
• Agree to participate and sign the informed consent.

You may not qualify if:

• Cannot accept catheter ablation (such as thrombus in left atrium/left atrial appendage, recent myocardial infarction, stroke, etc.);
• Patients with obvious bleeding tendency or unable to accept postoperative anticoagulation;
• The anteroposterior diameter of left atrium indicated by echocardiography was ≥50mm;
• A history of left atrial surgery or left atrial interventional therapy (including cryo-ablation, radiofrequency ablation, left atrial appendage occlusion, etc.);
• NYHA grade IV congestive heart failure or LVEF \<30%;
• patients with valvular atrial fibrillation and secondary atrial fibrillation (such as uncontrolled hyperthyroidism, acute alcoholism, atrial fibrillation after cardiac surgery, etc.);
• Patients with typical atrial fluttering or other supraventricular tachycardia (duration greater than 30s) confirmed by preoperative electrocardiogram or dynamic electrocardiogram;
• Severe organic heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
• Patients with secondary hypertension;
• Uncontrollable pulmonary hypertension;
• Patients with glomerular filtration rate (EGFR) \< 45ml/min/1.73m2 or patients with chronic kidney disease, nephrotic syndrome, polycystic kidney disease and other renal diseases were estimated according to MDRD calculation method;
• inability to access the renal vascular system;
• Diameter of renal aorta less than 4 mm or length less than 20 mm;
• Hemodynamic or anatomical renal artery abnormalities or stenosis;
• A history of previous renal artery interventions, including balloon angioplasty or stenting;

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Central Study Contacts

Yi Zhang

CONTACT

18917686332; yizshcn@gmail.com

Yawei Xu

CONTACT

18917684008; 479267058@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We used participant single blindness. To ensure single blindness, femoral artery puncture and renal arteriography were performed in the control group after cryoablation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Hypertensive patients with symptomatic paroxysmal atrial fibrillation who are to be treated by cryoablation with substandard blood pressure (SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in the clinic with at least one antihypertensive drug)

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: August 27, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-05

Locations

CN (1)