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

Primary Purpose

Paroxysmal Atrial Fibrillation, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Renal artery cryoablation
Pulmonary vein cryoablation
Renal arteriography
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Renal artery cryoablation, Pulmonary vein cryoablation, One-stop cardio-renal combined cryoablation therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiology, Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RDN+PVI group

PVI only group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Differences in office blood pressure
Differences in blood pressure (SBP, DBP) between the two groups at 6 and 12 months after procedure compared to the baseline;

Full Information

First Posted
May 17, 2021
Last Updated
August 21, 2021
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05024630
Brief Title
Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Hypertension
Keywords
Renal artery cryoablation, Pulmonary vein cryoablation, One-stop cardio-renal combined cryoablation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
Participant
Masking Description
We used participant single blindness. To ensure single blindness, femoral artery puncture and renal arteriography were performed in the control group after cryoablation.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RDN+PVI group
Arm Type
Experimental
Arm Description
The experimental group received renal artery cryoablation and pulmonary vein cryoablation. Pulmonary vein cryoablation was first followed by renal artery cryoablation.
Arm Title
PVI only group
Arm Type
Sham Comparator
Arm Description
The control group received pulmonary vein cryoablation alone. To ensure single blindness, the control group received femoral artery puncture and renal arteriography after cryoablation.
Intervention Type
Procedure
Intervention Name(s)
Renal artery cryoablation
Intervention Description
Renal denervation were achieved by cryoablation of renal artery with cryoballoon.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein cryoablation
Intervention Description
Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.
Intervention Type
Procedure
Intervention Name(s)
Renal arteriography
Intervention Description
Renal artery was examined by renal arteriography
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Description
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.
Time Frame
Within 12 months after procedure (outside the 90-day blanking period).
Secondary Outcome Measure Information:
Title
Differences in office blood pressure
Description
Differences in blood pressure (SBP, DBP) between the two groups at 6 and 12 months after procedure compared to the baseline;
Time Frame
Within 12 months after procedure.
Other Pre-specified Outcome Measures:
Title
Differences in 24-hour dynamic blood pressure
Description
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;
Time Frame
Within 12 months after procedure.
Title
Differences in self-measured blood pressure
Description
Differences in mean self-measured blood pressure (SBP, DBP) from baseline in the two groups at 3, 6, 9 and 12 months after procedure;
Time Frame
Within 12 months after procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Renal artery imaging (renal artery CTA) exclusion criteria: 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; There are multiple unilateral renal aortas leading to the kidney; Participated in other clinical studies and not yet enrolled in the group; Women who are pregnant, lactating or preparing to become pregnant; Life expectancy less than 1 year; Other conditions that are not suitable for inclusion in this study as assessed by the researcher, such as mental disorders or psychological disorders; 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; Patients with ICD implantation history or CRT treatment history.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Zhang
Phone
18917686332
Email
yizshcn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yawei Xu
Phone
18917684008
Email
479267058@qq.com
Facility Information:
Facility Name
Department of Cardiology, Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19720958
Citation
Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009 Oct;54(4):690-7. doi: 10.1161/HYPERTENSIONAHA.108.119883. Epub 2009 Aug 31.
Results Reference
background
PubMed Identifier
19822798
Citation
Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.
Results Reference
background
PubMed Identifier
17394967
Citation
Arora R, Ng J, Ulphani J, Mylonas I, Subacius H, Shade G, Gordon D, Morris A, He X, Lu Y, Belin R, Goldberger JJ, Kadish AH. Unique autonomic profile of the pulmonary veins and posterior left atrium. J Am Coll Cardiol. 2007 Mar 27;49(12):1340-8. doi: 10.1016/j.jacc.2006.10.075. Epub 2007 Mar 12.
Results Reference
background
PubMed Identifier
7733127
Citation
Krahn AD, Manfreda J, Tate RB, Mathewson FA, Cuddy TE. The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med. 1995 May;98(5):476-84. doi: 10.1016/S0002-9343(99)80348-9.
Results Reference
background
PubMed Identifier
8114238
Citation
Benjamin EJ, Levy D, Vaziri SM, D'Agostino RB, Belanger AJ, Wolf PA. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA. 1994 Mar 16;271(11):840-4.
Results Reference
background
PubMed Identifier
19549038
Citation
Joshi S, Choi AD, Kamath GS, Raiszadeh F, Marrero D, Badheka A, Mittal S, Steinberg JS. Prevalence, predictors, and prognosis of atrial fibrillation early after pulmonary vein isolation: findings from 3 months of continuous automatic ECG loop recordings. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1089-94. doi: 10.1111/j.1540-8167.2009.01506.x. Epub 2009 Jun 22.
Results Reference
background
PubMed Identifier
19710497
Citation
Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available.
Results Reference
background
PubMed Identifier
24210779
Citation
Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7. Erratum In: Lancet. 2014 Feb 15;383(9917):602. Sobotka, Paul A [added].
Results Reference
background
PubMed Identifier
21093036
Citation
Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
Results Reference
background
PubMed Identifier
24678939
Citation
Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
Results Reference
background
PubMed Identifier
32234534
Citation
Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.
Results Reference
background
PubMed Identifier
29803589
Citation
Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
Results Reference
background
PubMed Identifier
29803590
Citation
Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23. Erratum In: Lancet. 2018 Sep 8;392(10150):820.
Results Reference
background
PubMed Identifier
25256203
Citation
Prochnau D, Heymel S, Otto S, Figulla HR, Surber R. Renal denervation with cryoenergy as second-line option is effective in the treatment of resistant hypertension in non-responders to radiofrequency ablation. EuroIntervention. 2014 Sep;10(5):640-5. doi: 10.4244/EIJV10I5A110.
Results Reference
background
PubMed Identifier
33197159
Citation
Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
Results Reference
background
PubMed Identifier
27042964
Citation
Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
Results Reference
background
PubMed Identifier
33197158
Citation
Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.
Results Reference
background
PubMed Identifier
22958958
Citation
Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol. 2012 Sep 25;60(13):1163-70. doi: 10.1016/j.jacc.2012.05.036. Epub 2012 Sep 5.
Results Reference
background
PubMed Identifier
31961420
Citation
Steinberg JS, Shabanov V, Ponomarev D, Losik D, Ivanickiy E, Kropotkin E, Polyakov K, Ptaszynski P, Keweloh B, Yao CJ, Pokushalov EA, Romanov AB. Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):248-255. doi: 10.1001/jama.2019.21187. Erratum In: JAMA. 2020 Mar 3;323(9):896.
Results Reference
background

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

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