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

August 21, 2021 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Atrial fIbrillation reCurrence Among Patients With Paroxysmal Atrial Fibrillation and Uncontrolled hypErtension: the DUAL-ICE Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypertension is a major risk factor for the high morbidity and mortality of cardiovascular diseases in the world. As a common arrhythmia, the autonomic nervous system plays an important role in the occurrence and maintenance of atrial fibrillation [1,2]. Enhancement of central sympathetic nervous system activity and stimulation of the efferent sympathetic nerve of the heart can promote the occurrence and development of atrial fibrillation [3]. Hypertension is an important risk factor for the occurrence of atrial fibrillation, and the incidence of complications such as heart failure, coronary heart disease and left ventricular hypertrophy is increased in patients with atrial fibrillation with poor blood pressure control [4-6]. Therefore, hypertension management in patients with atrial fibrillation is particularly important.

However, a 2014 study of SYMPLICITY HTN-3 with a sample size of 535 people showed that RDN could not significantly reduce blood pressure [10], which put the study of RDN into a dilemma. Since then, researchers have optimized the study design, and some more detailed results have suggested a significant antihypertensive effect of RDN [11-13].

At present, there are few reports on the cryo-ablation of renal sympathetic nerve in the RDN studies, only the case of cryo-ablation of renal artery by Dr.Prochnau et al in Germany in 2014, which is still a technical blank in China [14]. At present, catheter ablation has been widely recognized in the treatment of paroxysmal atrial fibrillation. In terms of patient comfort and efficacy, cryo-ablation promoted in recent years shows greater advantages than radiofrequency ablation, which has the characteristics of less damage to surrounding tissues and faster recovery of vascular endothelial function. Therefore, the application of cryoablation in the field of RDN may be similar to the effect of pulmonary vein ablation. The purpose of our study was to investigate whether renal artery cryoablation combined with pulmonary vein cryoablation reduces the recurrence rate of atrial fibrillation compared with pulmonary vein cryoablation alone.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Department of Cardiology, Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years old, and <75 years old, gender is not limited;
  2. 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;
  3. Agree to participate and sign the informed consent.

Exclusion Criteria:

  1. Cannot accept catheter ablation (such as thrombus in left atrium/left atrial appendage, recent myocardial infarction, stroke, etc.);
  2. Patients with obvious bleeding tendency or unable to accept postoperative anticoagulation;
  3. The anteroposterior diameter of left atrium indicated by echocardiography was ≥50mm;
  4. A history of left atrial surgery or left atrial interventional therapy (including cryo-ablation, radiofrequency ablation, left atrial appendage occlusion, etc.);
  5. NYHA grade IV congestive heart failure or LVEF <30%;
  6. patients with valvular atrial fibrillation and secondary atrial fibrillation (such as uncontrolled hyperthyroidism, acute alcoholism, atrial fibrillation after cardiac surgery, etc.);
  7. Patients with typical atrial fluttering or other supraventricular tachycardia (duration greater than 30s) confirmed by preoperative electrocardiogram or dynamic electrocardiogram;
  8. Severe organic heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
  9. Patients with secondary hypertension;
  10. Uncontrollable pulmonary hypertension;
  11. 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;

  12. Renal artery imaging (renal artery CTA) exclusion criteria:

    1. inability to access the renal vascular system;
    2. Diameter of renal aorta less than 4 mm or length less than 20 mm;
    3. Hemodynamic or anatomical renal artery abnormalities or stenosis;
    4. A history of previous renal artery interventions, including balloon angioplasty or stenting;
    5. There are multiple unilateral renal aortas leading to the kidney;
  13. Participated in other clinical studies and not yet enrolled in the group;
  14. Women who are pregnant, lactating or preparing to become pregnant;
  15. Life expectancy less than 1 year;
  16. Other conditions that are not suitable for inclusion in this study as assessed by the researcher, such as mental disorders or psychological disorders;
  17. A history of acute coronary events or percutaneous coronary stent intervention, a history of stroke or transient ischemic attack, and extensive atherosclerosis with intravascular thrombosis within the last 6 months;
  18. Patients with ICD implantation history or CRT treatment history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RDN+PVI group
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
Renal denervation were achieved by cryoablation of renal artery with cryoballoon.
Procedure: Pulmonary vein cryoablation
Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.
Sham Comparator: PVI only group
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
Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.
Procedure: Renal arteriography
Renal artery was examined by renal arteriography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of atrial fibrillation
Time Frame: Within 12 months after procedure (outside the 90-day blanking period).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in office blood pressure
Time Frame: Within 12 months after procedure.
Differences in blood pressure (SBP, DBP) between the two groups at 6 and 12 months after procedure compared to the baseline;
Within 12 months after procedure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in 24-hour dynamic blood pressure
Time Frame: Within 12 months after procedure.
The difference of 24h-SBP/DBP mean value (daytime, night and whole day) between the two groups at 6 and 12 months after procedure compared to the baseline level;
Within 12 months after procedure.
Differences in self-measured blood pressure
Time Frame: Within 12 months after procedure.
Differences in mean self-measured blood pressure (SBP, DBP) from baseline in the two groups at 3, 6, 9 and 12 months after procedure;
Within 12 months after procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUAL-ICE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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